Guidelines for the use of mifepristone medical abortion in new

Guidelines for the Use of Mifepristone for
Medical Abortion in New Zealand
Abbreviations used in this document.61. Introduction.72. Background.7 2.1 Approval of mifepristone (Mifegyne) in New Zealand.72.2 Legal requirements.7 3. Second Trimester Abortion.8 3.1 Background.83.2 Mifepristone dosage.83.3 The prostaglandin.83.4Interval between mifepristone and the prostaglandin.93.5 Second trimester protocols.9 4. First Trimester Medical Abortion.10 4.1 Background.104.2Gestational age.10 4.2.1 Registered use.104.2.2 49-63 days' gestation.104.2.3 9-13 weeks' gestation.114.2.4 Early pregnancy with no visualised sac.114.2.5 Summary.11 4.3 The method.11 4.3.1 Mifepristone dosage.114.3.2 Interval between mifepristone and misoprostol.114.3.3 The prostaglandin – misoprostol or gemeprost.124.3.4 Route of administration of misoprostol.124.3.5 Dose of misoprostol.124.3.6 Informed consent.12 4.4 Management in clinic or at home.13 4.4.1 After mifepristone administration.134.4.2 After misoprostol administration.134.4.3 Assessment of patients for early discharge after misoprostol.134.4.4Clinic ability to support patient at home.14 4.5 Medical follow-up after first trimester medical abortion.14 4.5.1 Evidence.144.5.2 Recommendations for follow-up.144.5.3 Use of βhCG and USS for follow-up.15 4.5.4 Follow-up of women who fail to attend appointments.164.5.5 Specialist follow-up of complications of medical abortion.16 4.6 Patient acceptability.164.7Management of pain.17 4.7.1 Non-medical pain management strategies.174.7.2Analgesia.18 4.8 Back-up medical services.18 5. Drugs – Actions, Interactions and Contraindications.19 5.1 Drug names.195.2 Drug actions.195.3 Presentation and storage.195.4 Cost of the drugs.195.5 Contraindications to mifepristone / prostaglandin abortion.19 5.5.1 Absolute contraindications.195.5.2 Relative contraindications.19 5.6 Side effects.20 5.6.1 After mifepristone administration.205.6.2 After misoprostol administration.20 6. Model Process for First Trimester Medical Abortions.22 6.1 Patient referral.226.2 Client profile.226.3 First clinic visit – Day 1.22 6.3.1 Counselling.236.3.2Medical assessment.236.3.3 Nurse/midwife care.246.3.4 Administration of the treatment.246.3.5 Support for patient at home during interval between mifepristoneand misoprostol.24 6.4 Second clinic visit – Day 2.25 6.4.1 Discharge home immediately after misoprostol administration.256.4.2 Patient remaining in clinic after misoprostol administration.256.4.3 Analgesia.266.4.4 Possible complications.266.4.5 Failure to complete under clinic observation.26 6.5 Final medical consultation to ensure abortion is complete.26 7. Premises and Facilities.27 7.1 In the clinic.277.2 At home.287.3 Ultrasound.287.4 Written materials.28 8. Staffing and Staff Training.29 8.1 Staffing levels.298.2 Provider acceptability.298.3 Role of nurse/midwife.298.4 Staff training for medical abortion.30 8.4.1 Introduction.308.4.2Training for referring agencies.318.4.3 Administrative staff.318.4.4Training for counsellors.318.4.5 Medical staff training.328.4.6 Nurse/midwife training.328.4.7 Training for specialist services.328.4.8 Training for second trimester services.32 9. Counselling for Medical Abortion.34 9.1 General.349.2 Social factors.349.3 Support.359.4 Psychological and emotional factors.359.5 Second trimester abortions.359.6 Other issues.36 10.Management of Fetal Tissue.3711. Evaluation and Audit.38 11.1 Audit in the clinic.3811.2 National audit.3811.3 Abortion Supervisory Committee.38 References 40Appendix 1 - Data Sheet- Mifegyne 200 Mg Appendix 2 - Istar LimitedAppendix 3 - Sample Consent FormsAppendix 4 - On-Call Medical Abortion Telephone Assessment GuideAppendix 5 - General Guide for initiation of Medical Abortion ServicesAppendix 6 - Sample Patient Information PamphletsAppendix 7 - Information For Referring DoctorsAppendix 8 - Management Of Side Effects And Complications Of Early Medical Termination of Pregnancy Appendix 9 - Level J Unit Client Information Sheet – Pregnancy Tissue Abbreviations used in this document
beta human chorionic gonadotrophin
Abortion Supervisory Committee
CS & A Act Contraception, Sterilisation, and Abortion Act 1977
BPAS
British Pregnancy Advisory Service
intrauterine contraceptive device
Non-steroidal anti-inflammatory drug
Royal College of Obstetricians and Gynaecologists
retained products of conception
Termination of pregnancy
In May 2003 the Abortion Supervisory Committee (ASC) appointed a technical
committee to advise it on the use of mifepristone for medical abortion in New
Zealand. The technical committee was asked to develop guidelines and report back
within three months.
The members of the technical committee were Miss Vasudha Iyengar, Ms Hazel
Irvine and Dr Carol Shand *. Mr John Tait provided additional advice during Miss
Iyengar's absence overseas. They sought input from Annie Muirgen, Senior Social
Worker at the Level J Unit, and Janet Campbell, counselling advisor to the ASC.
The aim of these guidelines is to provide information to ensure the provision of
clinically safe, evidence-based medical abortion that meets New Zealand legal
requirements and is cost-effective.
Approval of mifepristone (Mifegyne) in New Zealand
In March 2001 the Medicines Advisory Committee recommended that Mifegyne beapproved under Section 21 of the Medicines Act 1981 for use in the followingindications:• As a medical alternative to surgical termination of intra-uterine pregnancy• Softening and dilation of the cervix uteri prior to surgical termination of intra- uterine pregnancy • Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons • Labour induction for the expulsion of a dead foetus (foetal death in utero) Mifegyne was gazetted for use in New Zealand in August 2001 (see Appendix 1,Mifegyne data sheet).
Mifegyne is manufactured in France for Exelgyn and imported into New Zealand bya not-for-profit company, Istar Limited. See Appendix 2 for information on how toorder supplies.
Where possible in this document the generic names of drugs will be used, i.e.
Mifegyne will be referred to by its generic name, mifepristone.
For the purposes of this clinical document, compliance with the legal requirements ofabortion is assumed.
Miss Vasu Iyengar, MBS, MRCOG, FRANZCOG, CCT Obstetrician and Gynaecologist, Capital & Coast District Health BoardMs Hazel Irvine, NZRGON, NZRM, MNZAP, Service Leader Level J Unit, Capital & Coast DistrictHealth BoardDr Carol Shand, MB, ChB, FACSHP, FRNZCGP, General Practitioner and Sexual Heath Physician,Operating doctor Level J Unit, Capital & Coast District Health Board, Director Istar Ltd.
Second Trimester Abortion
Second Trimester Abortion
Late mid-trimester medical termination of pregnancy with mifepristone followed bythe prostaglandin misoprostol is now the most commonly used method in six of thelarger units in New Zealand. The experience of these units is very positive and bothclient and provider satisfaction are anecdotally reported. This confirms overseasexperience.
Because the most commonly used method, in New Zealand, for second trimesterabortion (over 16 weeks) has been induction with a prostaglandin, it is simple to addmifepristone to this regime. It provides real advantages to both the women and theproviders:• The interval between the administration of the prostaglandin and delivery of the products is shortened from an average of 15.8 hours to 6.8 hours (Rodger and Baird1990; Urquhart and Templeton 1990).
• The amount of prostaglandin required is reduced.
• The cost of the procedure is consequently reduced despite the added cost of • The shortened time reduces the psychological stress on both the women and the The dose of mifepristone recommended in the data sheet and in early trials is 600 mg.
More recent published experience suggests that this can be reduced to 200 mg(Webster, Penney et al. 1996). The Royal College of Gynaecologists (RCOG 2000) intheir evidence-based guidelines state that a dose of 200 mg is adequate.
Early experience was with the prostaglandins dinoprostone and gemeprost, which areexpensive, unstable at room temperature and not provided in many New Zealandhospitals. Published trials comparing misoprostol with dinoprostone (Jain and Mishell1994) and gemeprost (el-Refaey, Hinshaw et al. 1993; Jain and Mishell 1994;Hinshaw, el-Refaey et al. 1995; Ho, Chan et al. 1996; le Roux, Pahal et al. 2001) haveshown that misoprostol is equally effective, produces fewer side effects and is cheaperand easier to use.
The New Zealand Mifegyne data sheet does not specify the prostaglandin or thedose to be used for mid-trimester induction.
Misoprostol is not registered anywhere for obstetric or gynaecological use. Itsregistered use is for prevention of gastric and duodenal ulcers associated with the useof non-steroidal anti-inflammatory drugs. The manufacturer, Searle, sent a letter toAmerican healthcare professionals in August 2000, elaborating on its data sheetwarning against the use of misoprostol in pregnant women.
Goldberg et al. (Goldberg, Greenberg et al. 2001) in the NEJM January 2001,reviewed the obstetric uses of misoprostol and concluded "misoprostol is one of themost important medications in obstetrical practice… The non experimental, off-label Second Trimester Abortion
use of a drug requires sound scientific evidence." The article summarises the "strongand consistent evidence" to support the use of misoprostol for induction of labour inthe second and third trimesters as well as its use in first trimester abortion, listing 95references. An editorial in the same issue (Hale and Zinberg 2001) followed by a letterfrom the manufacturer (Friedman 2001) continued the debate. Friedman stated "wefully support the role of physicians, using their professional judgement, to prescribean approved pharmaceutical product for a use outside of its FDA-approvedindication in the best interest of their patients, on the basis of published research,expert clinical opinion, or their own clinical experience." Because misoprostol is not registered for use in abortion, patients must sign aninformed consent, which states that the drug is not registered for this purpose, and thatthe use is evidence-based. Earlier licensed protocols all used oral prostaglandins. Some published studies suggestthat the use of vaginal misoprostol shortens the induction-abortion interval and lowersthe total dose of prostaglandin required (Ho, Ngai et al. 1997; Wong, Ngai et al.
2000). Templeton's Unit in Aberdeen published their comparison of regimes usingvaginal misoprostol with regimes using a combination of vaginal and oralmisoprostol, which showed no significant difference (el-Refaey and Templeton 1995).
Others have tried different regimens of vaginal dosing(Wong, Ngai et al. 2000).
3.4Interval between mifepristone and the prostaglandin
The Mifegyne data sheet recommendation is for a 36-48 hour interval. Publishedtrials that suggest that this interval may be shortened without significantly altering theoutcome have been done only in the first trimester (see 4.3.2). We are not aware ofany trials showing the impact of altering this interval in second trimester patients.
Some units which are familiar with offering prostaglandin-only inductions mayinitially find it difficult to ask the women to wait between the drugs. However mostunits find that this time spent in preparing for the induction process can be beneficialfor the women, and any extra anxiety is outweighed by the very significant benefits ofa shortened procedure on the second day.
Second trimester protocols
Protocols have been developed by Level J Unit in Wellington, National Women's andMiddlemore Hospitals in Auckland, Christchurch Women's Hospital and Queen MaryHospital in Dunedin.
There is some variation in these protocols. Most are providing abortion mainly forfetal anomaly. Any of the units may be contacted for advice.
First Trimester Medical Abortion
First Trimester Medical Abortion
Medical abortion is a safe, effective, acceptable method of termination for pregnanciesin the first trimester.
Medical abortion has been recommended by the Royal College of Obstetricians andGynaecologists (RCOG) in the United Kingdom as the method of choice for womenwith pregnancies of 49 days or less and as an appropriate method for women in the 7-9 week gestational band (RCOG 2000).
Medical abortion presents several advantages over a surgical procedure:• There is no risk of trauma to the cervix or uterus, such as perforation.
• There is no anaesthetic risk.
• It is non-invasive and therefore the risk of infection is less.
• Its safety does not depend upon operator skills.
• Many women perceive it to be more natural, less invasive, private and more under their control.
In many countries half of abortions within approved gestational limits are performedusing mifepristone, e.g. in France (56%), Scotland (61%) and Sweden (51%) (Jonesand Henshaw 2002), although the rate is much less in England.
4.2.1 Registered use
Mifegyne is approved under Section 21 of the Medicines Act 1981 for use as a
medical alternative to surgical termination of intra-uterine pregnancy. There is no
specified limit to the stage of pregnancy at which this method can be used.
The Mifegyne data sheet (see Appendix 1), which supports this usage, recommends
the following dosage and administration:
"As a medical alternative to surgical termination of intra-uterine pregnancy in early
pregnancy: 600 mg mifepristone (3 tablets) in a single oral dose followed 36-48 hrs
later, by the administration of a prostaglandin analogue; misoprostol 400 mcg orally
(up to 49 days) or gemeprost 1 mg vaginally (up to 63 days)."
4.2.2 49-63 days' gestation
As detailed below (4.3.3) recently published evidence supports the effectiveness and
safety of misoprostol as an alternative to gemeprost at a later gestational age of
pregnancy as well up to 49 days. Ashok et al. (Ashok, Templeton et al. 2002), with a
large series of over 4000 patients, demonstrated the safety and effectiveness of
medical termination up to 63 days of pregnancy.
With most published regimes the greater the gestation, the more reported risk there is
of failure and of complications (McKinley, Thong et al. 1993; Ashok, Penney et al.
1998). More recently, however, Ashok et al., in their review of over 4000 medical
abortions up to 63 days' gestation (Ashok, Templeton et al. 2002) using a second dose
of misoprostol after 4 hours if abortion does not appear imminent, show no significant
difference in outcome between <49 and <63 days.
First Trimester Medical Abortion
4.2.3 9-13 weeks' gestation
Other published experience demonstrates the safety of medical termination with
mifepristone during the 9 to 13 week period (Ashok, Flett et al. 1998; Carbonell
Esteve, Varela et al. 1998; Carbonell, Varela et al. 1999; Ashok, Kidd et al. 2002;
Hamoda, Ashok et al. 2003).
4.2.4 Early pregnancy with no visualised sac
How early in pregnancy can medical abortion be safely performed? When
ultrasonography is performed in very early pregnancy, the findings are not always
conclusive in both identifying an intrauterine gestation and excluding an ectopic
pregnancy. Transvaginal probe is essential to identify a sac in very early pregnancy.
There is no general agreement about management of early medical termination before
the sac is visualised. Fjerstad and Creinin (Fjerstad and Creinin 2003) have discussed
the relevant issues. Schaff (Schaff, Fielding et al. 2001) published a series of 30 early
medical abortions when no sac was present. Many users still prefer to delay the
termination until a sac can be visualised, to exclude the presence of an ectopic
pregnancy.
Correlation with serum βhCG is useful. Women with levels >2000 IU/L for vaginal
probe or >3600 IU/L for abdominal probe but no sac demonstrated should be
investigated for ectopic pregnancy.
4.2.5 Summary
In clinically controlled circumstances medical abortion remains an alternative to
surgical abortion at any gestational age. Beyond 63 days of pregnancy, present
knowledge indicates that women should remain in a clinic or hospital until the
termination is completed, as there is no published clinical experience to support safety
of termination at home.
The method
The New Zealand data sheet (Appendix 1) recommends Mifegyne 600 mg followed36-48 hours later by misoprostol 400 mcg orally (up to 49 days) or gemeprost 1 mgvaginally (up to 63 days).
Peer reviewed published literature includes a range of other protocols with varyingdoses and, for misoprostol, route of administration.
4.3.1 Mifepristone dosage
Studies using 200 mg of mifepristone instead of 600 mg show no statistical difference
in efficacy between the two doses (McKinley, Thong et al. 1993; 1999; Schaff,
Eisinger et al. 1999; 2000). This is the dose recommended by the RCOG in their
evidence-based guideline (RCOG 2000).
It is possible that this dose will be able to be lowered further. Creinin at al. (Creinin,
Pymar et al. 2001) used 100 mg with results as good as 200 mg.
4.3.2 Interval between mifepristone and misoprostol
The approved protocol is for an interval of 36-48 hours between the mifepristone and
the prostaglandin. More recent publications have suggested that this is not essential. A
randomised trial showed no difference in results when misoprostol was taken 1-3 days
after mifepristone (Schaff, Fielding et al. 2000; Creinin, Schwartz et al. 2001; Pymar,
Creinin et al. 2001; Fox, Creinin et al. 2002).
First Trimester Medical Abortion
4.3.3 The prostaglandin – misoprostol or gemeprost
The approved protocol in New Zealand recommends using misoprostol up to 49 days'
gestation and gemeprost from 50-63 days' gestation (New Zealand data sheet,
Appendix 1).
Gemeprost (Cervagem) is an expensive prostaglandin, unstable at room
temperature, and not provided in many New Zealand units.
Recent published experience has shown misoprostol (Cytotec) to be safer and more
effective than gemeprost at every gestation (el-Refaey, Hinshaw et al. 1993; Baird,
Sukcharoen et al. 1995; Bartley, Brown et al. 2001).
The RCOG in their evidence-based guideline (RCOG 2000) state that "Misoprostol (a
prostaglandin E1 analogue) given vaginally is a cost-effective alternative for all
abortion procedures for which the E1 analogue gemeprost is conventionally used
(early medical abortion, cervical priming, mid-trimester abortion)."
4.3.4 Route of administration of misoprostol
In a review article in the NEJM (Goldberg, Greenberg et al. 2001) the authors point
out that only regimes of mifepristone in combination with oral (not vaginal)
misoprostol have been licensed for abortion in any country. They also observe that:
"The effects of misoprostol on the reproductive tract are increased and
gastrointestinal adverse effects decreased if the oral preparation of misoprostol is
administered vaginally."
Studies where direct comparisons have been made show vaginal misoprostol to be
more effective than oral misoprostol and with fewer side-effects (el-Refaey, Rajasekar
et al. 1995; Aubeny and Chatellier 2000; Goldberg, Greenberg et al. 2001; von
Hertzen, Honkanen et al. 2003).
4.3.5 Dose of misoprostol
Recent studies using 800 µg administered vaginally have shown results with more
than 90% completion within 4 hours (el-Refaey, Rajasekar et al. 1995).
Mifepristone 200 mg followed by vaginal administration of misoprostol 800 µg is
now the "evidence-based protocol" used in Planned Parenthood clinics in the USA
and in many UK clinics. As this is not the approved dose, informed patient consent is
required.
In their published series of over 4000 abortions Ashok et al. introduced a second dose
of misoprostol 400 µg given either vaginally or orally after 4-5 hours if abortion is not
imminent. This increases the effectiveness, particularly in pregnancies of 50-63 days
(Ashok, Templeton et al. 2002). A very recent WHO study (von Hertzen, Honkanen et
al. 2003) comparing various regimes of misoprostol showed a similar increased
effectiveness in gestations of 57-63 days when 800 µg of vaginal misoprostol is
followed by 400 µg p.o. bid for 7 days.
4.3.6 Informed consent
Patient consent is required to adhere to the Istar-Exelgyn agreement (see Appendix 2).
For any variations from the Mifegyne or Cytotec data sheets, further consent
specific for the variations must be obtained. Patient information should clearly explain
that the variations are evidence-based and the evidence must be available for patients
First Trimester Medical Abortion
to consult if they wish. Appendix 3 contains sample consent forms containing thesemodifications.
Management in clinic or at home
New Zealand law requires women to be in the licensed institution for theadministration of both abortifacient drugs. However the choice as to whether thewomen remain in the clinic, and for how long, will have to be made by the individualclinic and clinician. Where possible, they will involve the woman in this decision,depending on her circumstances.
4.4.1 After mifepristone administration
After administration of mifepristone women need remain in the clinic for only a short
period of time, to ensure the dose is not vomited and the patient is clinically stable. If
the dose is vomited another can be given (a wait of 30-60 minutes is suggested).
4.4.2 After misoprostol administration
There is now a large volume of international experience with early medical
termination:
• In the USA the vast majority of women self-administer the prostaglandin
(misoprostol 800 mcg vaginally) at home.
• Some UK clinics, such as British Pregnancy Advisory Service (BPAS), have now completed a trial of allowing women to go home immediately after theadministration of misoprostol. The data from this trial have not been published butare available from the authors on request if used to inform clinics on developingappropriate practice. • In most UK clinics women are encouraged to stay on the premises 4-6 hours after misoprostol is administered. The vast majority of these women will complete thetermination in that time. El Refaey et al. found 99% completed their abortionswithin 4 hours (el-Refaey and Templeton 1994). Those who do not may go homeand will require follow-up to ensure completion.
• The Level J Unit, Wellington, audited its first year of use under the restrictive interpretation of the New Zealand law that required abortion to be completedbefore patients were allowed to go home. Of 65 patients: one aborted aftermifepristone; 64 were given misoprostol; 60 of 64 successfully completed on theward in less than 8 hours; 4 of 64 were given suction curettage after 8 hours; ofthose 4 none had visible products (in 3 histology confirmed chorionic villi) butnone had any post-discharge problems.
4.4.3 Assessment of patients for early discharge after misoprostol
Fully informed patient choice must be the most important factor.
Emergency specialist services must be available (within two hours' travelling time).
The women need to have:
• access to a telephone (not toll-barred) to be able to contact the clinic/after-care
• reliable transport or money for taxis to attend emergency services if there are • access to toilet, shower/bath, laundry facilities• support at home First Trimester Medical Abortion
• the ability to cope independently both with pain and with bleeding• written information about the process and the drugs used • preparation for what the pregnancy tissue may look like• the ability to identify problems and knowledge of how to act on them• residence or other accommodation close to the clinic or hospital – the abortion process may take place 30-60 minutes after administration of misoprostol • either the ability to communicate clearly in English or a support person who will remain with her who speaks good English, or the clinic can provide staff whospeak the language of the patient.
4.4.4 Clinic ability to support patient at home
24-hour on-call patient advice is essential for management of medical abortion both in
the interval between the administration of mifepristone and misoprostol and for any
patients who are discharged home after misoprostol without having passed the
products of conception. This support must be given by staff who are experienced and
informed about management of medical abortion and who can talk the woman through
the process if she is distressed by the amount of pain and bleeding which normally
accompanies early medical abortion as well as advise on management of any serious
complications.
Some clinics have expressed concern that providing on-call patient advice will not be
possible within their service and this will prevent them offering early medical abortion
to their patients. Given the small population of New Zealand a cost-effective way to
overcome this problem could be easily devised by cooperation between clinics
providing early medical termination of pregnancy.
The British Pregnancy Advisory Service and Marie Stopes International each run a
national emergency number for after-hours calls for the whole of their UK services.
Medical follow-up after first trimester medical abortion
4.5.1 Evidence
While the combination of mifepristone and misoprostol is a very good method for the
termination of pregnancy, agreement on the best method of evaluating its outcome and
follow-up protocols is still in its infancy. Several recent papers are beginning to
evaluate the best outcome measures (Creinin 1996; Paul, Schaff et al. 2000; Creinin,
Meyn et al. 2001; Harwood, Meckstroth et al. 2001; Walker, Schaff et al. 2001; Fiala,
Safar et al. 2003). Some consensus recommendations are reported below.
Sequential serum βhCG measurements have been evaluated in small studies. These
measurements are the best method available currently for evaluating the completion of
medical termination at follow-up. If the levels are static or rising, they must be used in
conjunction with transvaginal ultrasound scan (USS) follow-up of the endometrial
thickness (diameter of retained products of conception) measurements. USS on its
own is less reliable than βhCG measurement, especially with very early pregnancy.
4.5.2 Recommendations for follow-up
The following recommendations are made for the appropriate follow-up of women
who have undergone medical abortion:
First Trimester Medical Abortion
A) For women where the sac has clearly been identified as having been passed
on site after medical termination of pregnancy:
• Women should have a clear understanding of how to recognise complications
such as bleeding or infection and how and where to access help.
• A return visit to the clinic or to their referring doctor is recommended at 10-14 days after misoprostol administration.
• The visit should include an assessment of symptomatology and full pelvic examination where indicated.
B) For women where the sac has not been clearly identified as having been
passed at medical termination of pregnancy on site:
• Women should have a clear understanding of how to recognise complications
such as bleeding or infection and how and where to access help.
• The woman must at discharge be given clear instructions, both in writing and verbally, on the time, date and place of the follow-up appointment that she willattend.
• A return visit to the clinic or to the referring doctor is mandatory at 10-14 • There must be clear communication between clinic staff and the follow-up doctor about arrangements for serum βhCG tests. A laboratory request formshould be given to the woman, with written and verbal instructions that she isto have the blood taken 2 days before her follow-up appointment. The requestform should specify that the laboratory is to send copies of the result to boththe follow-up doctor and the TOP clinic.
• The follow-up visit should include full evaluation of the history, symptomatology and a pelvic examination where indicated. Confirmation isneeded that the pregnancy has been terminated and that there are nocomplications.
4.5.3 Use of βhCG and USS for follow-up
The following are the recommended protocols for serum βhCG and USS follow-up of
women who have undergone medical termination of pregnancy and have not had
documented evidence of passage of sac:
• Blood for a base-line serum βhCG measurement can be taken before discharge
from the clinic, with a copy to the follow-up doctor.
• Serum βhCG levels, at two weeks after early termination of pregnancy, of less than 80 i.u. indicate completion of the TOP [or <20% of the base-line value (Fiala,Safar et al. 2003)].
• If levels are higher than this at 2 weeks repeat in 72 hours; if the levels drop at a second measurement then surgical evacuation is not required.
• If level is static or rising then arrange transvaginal USS.
• If USS shows viable intrauterine pregnancy then refer for surgical termination.
• If USS shows a sac still present (but no cardiac activity) and the patient has no heavy bleeding, a second dose of misoprostol may be given (refer back to TOPclinic), or the patient may be given the option of waiting until 6 weeks post-abortion to pass the sac on her own.
First Trimester Medical Abortion
• If the patient is having prolonged heavy bleeding referral for surgical termination of pregnancy may be appropriate. • No USS for assessing retained products of conception (RPOC) at least until 2 weeks have elapsed. This minimises the rate of unnecessary surgical evacuations.
• At two weeks USS evidence of RPOC described to be of a size greater than 5 cm in diameter and accompanied by heavy vaginal bleeding requires surgical
evacuation.
At any stage in the process if the woman requests referral for surgical abortion, thenthis should be done.
4.5.4 Follow-up of women who fail to attend appointments
If completion of the abortion has not been confirmed in the clinic, there should be
close communication between the referring doctor and the TOP clinic to ensure the
follow-up takes place. Women will have signed a consent form agreeing to this
follow-up appointment. If the woman does not attend then there must be agreement as
to who takes responsibility for making contact with her.
The minimum effort that should be made is a telephone call followed by a letter to a
safe address confirmed with the woman in advance (or the letter avoids any mention
of the abortion). These should be carefully documented. There will be some women
who do not attend despite the best attempts by providers.
4.5.5 Specialist follow-up of complications of medical abortion
In the US and UK most units provide their own follow-up and many have on-site
ultrasound facilities and specialist management of complications. Most abortion units
report that as their experience of medical abortion increases the need for surgical
interference is reduced.
In New Zealand specialist management of complications will usually be by
gynaecologists whose experience of early medical abortion is minimal. Information
and education of gynaecologists in New Zealand on management of complications of
medical abortion would minimise unnecessary surgery.
All regimes report high rates of patient satisfaction (1998; Winikoff, Ellertson et al.
1998; Clark, Ellertson et al. 2000; Elul, Pearlman et al. 2000; Jensen, Harvey et al.
2000; Rosing and Archbald 2000). Poenariu prepared a review for the 12thpostgraduate course in reproductive medicine and biology, Geneva, Switzerland,which is available off the Internet. This review summarises the conclusions drawn andrecommendations made by previous research (Poenariu 2003) including the papersmentioned above, but in particular those which give comparisons between surgicaland medical abortion.
Clark et al. (Clark, Ellertson et al. 2000) reviewed the data on American women fromthe large multi-centre study of 2121 women in diverse sociodemographicbackgrounds. They showed that women from a wide array of backgrounds foundmedical abortion highly acceptable, but that they choose and prefer it for differentreasons. In this trial even those women who had failures appeared to be almostuniversally supportive of this method and no group or type of women found it largelyunacceptable. Winikoff et al. showed similar acceptability of medical abortion indifferent cultures (Winikoff, Sivin et al. 1997).
First Trimester Medical Abortion
There is a need for New Zealand research, to determine if local women also find thatthe method is acceptable.
4.7Management of pain
Pain remains a decisive factor for women in the decision making process of abortion.
Pain management should be based on the principles of general pain management,
which can involve relatively simple and non-expensive interventions, both medical
and non-medical.
Studies show pain is less severe with abortions at earlier gestations, at less than 50
days compared with 50-63 days (Spitz, Bardin et al. 1998). So every effort should be
made to ensure early diagnosis and referral, with no waiting lists for medical abortion.
Christian Fiala, MPH Programme Director Reproductive Health for the Population
Council, USA, reported on pain management at the British Pregnancy Advisory
Service International Symposium on Abortion Care in 2001 (Fiala 2001).
Women report less pain when the choice of early medical abortion has been their own
decision, and when they have accurate information before the procedure and high
quality care throughout. Women who receive a description of the sensations
accompanying a procedure have less distress than do those informed only of the
procedure itself (Johnson 1973).
Parity has a significant influence on pain (Westhoff, Dasmahapatra et al. 2000;
Suhonen, Heikinheimo et al. 2003) with primiparous women requiring significantly
more analgesia. Westhoff et al. found the use of narcotic analgesia (codeine) more
prevalent in women undergoing medical abortion at home than in women in a clinic
setting, but the most important determinant of narcotic was clinic providing care. Use
of narcotic analgesia was less prevalent among Asian women and among women with
a gestational age of 56 days or less (Westhoff, Dasmahapatra et al. 2000).
4.7.1 Non-medical pain management strategies
• Different women feel secure in different environments. Some women prefer the
security of a hospital environment; others prefer the comfort and privacy of theirown home.
• Women need to know what to expect in terms of pain, bleeding and other symptoms. Information given needs to be realistic and matter-of-fact, with animplicit expectation that the women will be able to manage (Murphy, Jordan et al.
2000).
• Bed versus couch – there is no clinical need for women to be in bed and some women are more comfortable if they are in a sitting-room environment (White1996; Fiala 2001).
• Separate room versus being together with other patients: some women prefer to be in the company of others undergoing the same experience. This can be achieved bymaking available a sitting-room with comfortable seating in addition to singlerecovery rooms.
• Emotional support is a significant factor in pain management (White 1996; Albers 1998). Nurses/midwives have a role in this (Albers 1998).
• Presence of a partner or support person – preference varies but most women would find it difficult for privacy, dignity and confidentiality not to have a private room ifsupport people or other women were present.
First Trimester Medical Abortion
• Simple care – a hot water bottle can be a most effective analgesic as can back-rubs, hot/cold packs to the lower abdomen, standing in a shower.
4.7.2 Analgesia
Non-steroidal anti-inflammatory drugs (NSAIDs):
• The Mifegyne data sheet states: "A decrease of the efficacy of the prostaglandin
can theoretically occur due to the antiprostaglandin properties of non-steroidalanti-inflammatory drugs NSAIDs." • More recent studies do not support this concern (Creinin and Shulman 1997). Ivy et al. (Ivy, Grace et al. 2003) in a double blind randomised control study showed noantiprostaglandin effect on cervical ripening but also no reduction in pain ofsurgical TOP.
• Current opinion is that there is no evidence that NSAIDs affect the efficacy of medical abortion with mifepristone/prostaglandin and there are some goodarguments for their use. Kruse et al. (Kruse, Poppema et al. 2000) state "NSAIDssuch as ibuprofen are not contraindicated and their use does not decrease thelikelihood of abortion after prostaglandin analog administration." • The issue was further discussed at the International Symposium on Abortion Care organised by British Pregnancy Advisory Service, London, in 2001 (Fiala 2001)and concluded "Since NSAIDs inhibit new endogenous prostaglandin synthesisthey should have no adverse effect on exogenous prostaglandins." Analgesia during medical abortion can be based on the following plan: • Paracetamol is effective as first line treatment.
• An alternative is a NSAID such as naproxen sodium, ibuprofen or diclofenac.
• If further medication is needed codeine phosphate or tramadol can be used.
• In the in-patient setting there is the option to use a parenteral narcotic such as pethidine or fentanyl.
Some units give either paracetamol with or without codeine, or a NSAID at the sametime as or before the misoprostol as prophylaxis.
Analgesia is more effective if given before the pain becomes distressing (Fiala 2001). Back-up medical services
Early medical abortion can be provided in freestanding licensed abortion clinics. Theneed for easy access to emergency specialist gynaecological services for themanagement of complications is no different from that currently needed for surgicalabortion. However the specialist services will usually not be familiar with managingthe complications of medical abortion, which are not the same managementprocedures as those needed after surgical abortion.
Before offering early medical abortion clinics should have discussions with their localspecialist services to ensure that back-up will be provided and to set in place clearguidelines on how, when and where the specialist facility can be accessed. Combined training with the abortion clinic, referring doctors and specialist services onmanagement of complications of abortion as well as a process for review ofcomplications, would improve outcomes for women.
Drugs – Actions, Interactions
Drugs – Actions, Interactions and Contraindications
Drug names
Cytotec®, misoprostol
Mifegyne®, mifepristone (RU 486)
Drug actions
Mifepristone is a synthetic steroid derived from 19-nor-testosterone. It is a selective
progesterone receptor modulator (SPRM). It has an antiprogestogen effect produced
by blocking progesterone receptors (Leonhardt and Edwards 2002). It also binds to the
glucocorticoid receptors but not to the mineralocorticoid receptors.
Misoprostol is a synthetic prostaglandin E analogue which has a direct effect on the
uterus and cervix, causing uterine contractions and cervical dilatation.
Presentation and storage
Mifegyne (mifepristone) is presented as a 200-milligram tablet and Cytotec(misoprostol) as a 200-microgram tablet. Both are stored at room temperature.
Cost of the drugs
Mifegyne costs $180 for packets of 3 x 200 mg tablets.
Cytotec costs 47 cents per 200 mcg tablet.
Contraindications to mifepristone / prostaglandin abortion
See Mifegyne data sheet, Appendix 1.
5.5.1 Absolute contraindications
• Known hypersensitivity to prostaglandins, mifepristone or any component of the
• IUCD in situ after failure to remove• Chronic adrenal failure• Severe asthma uncontrolled by corticosteroid therapy• Porphyrias 5.5.2 Relative contraindications
• Corticosteroids – long term or current treatment
• For patients with asthma who use inhaled corticosteroid therapy it is
recommended that the dose be doubled during the 48 hours preceding theadministration of mifepristone and continued for about one week • Cardiovascular disease (angina, Raynaud's disease, cardiac arrhythmias, cardiac failure, severe hypertension) • Bleeding disorders• Multiple uterine scars or history of uterine rupture – this is a high risk situation and women should be fully informed about the risks. Specialist consultation isrecommended and a plan for careful maternal monitoring.
Drugs – Actions, Interactions
and Contraindications
• Women over 35 who smoke more than 10 cigarettes a day• In the absence of specific studies: o Breast feeding – mifepristone theoretically may be excreted in the milk. (It may consequently be advisable to recommend women to stop breast-feedingfor up to one week and to advise how to maintain milk supply by expressing) o Renal failure, liver failure or malnutrition.
Side effects
5.6.1 After mifepristone administration
Women who have smoked until just before the administration of this drug may
sometimes show some degree of "asthma" type symptoms due to bronchoconstriction.
This may be relieved by the use of beta agonist inhalers.
Women who vomit copiously within an hour of receiving the drug may not show its
full action as it may be brought up within the vomitus. (A second tablet of
mifepristone should be given if there is any doubt.)
More than 50% of patients will have some bleeding in the 48 hours after
administration of mifepristone and 2-5% of women will complete their abortion in
this time.
Teratogenicity: The Mifegyne data sheet states "Patients must be informed that in
the event of failure and a continuing pregnancy the foetus may be exposed to a risk of
malformation." The risk of malformation has not been clearly shown and if present is
significantly lower than that with misoprostol (Pons, Imbert et al. 1991; Pons and
Papiernik 1991; Sitruk-Ware, Davey et al. 1998).
5.6.2 After misoprostol administration
• Women will usually experience uterine contractions or cramping (10-45%) in the
hours following prostaglandin intake.
• Nausea, vomiting, and diarrhoea are very common after misoprostol but may be controlled with appropriate medication.
• All women will experience some bleeding. The amount increases with gestational age. Heavy bleeding occurs in about 5% of cases and from 0 – 4% may requirecurettage of the uterus for haemostasis.
• Uncommonly, hypotension (0.25%)• Uncommonly, skin rashes (0.2%). Single cases of urticaria, erythroderma, erythema nodosum and epidermal necrolysis have been reported.
• Vagal symptoms are common (hot flushes, dizziness, chills). Fever is uncommon. • Rare cases of headaches and of malaise have been reported.
• Misoprostol is known to be teratogenic in the first trimester. Mobius' syndrome (congenital facial paralysis) and limb defects have occurred in the infants ofwomen who have taken misoprostol during the first trimester in unsuccessfulattempts to induce abortion (Gonzalez, Vargas et al. 1993; Pastuszak, Schuler et al.
1998; Sitruk-Ware, Davey et al. 1998). In a more recent study (Orioli and Castilla2000) of infants exposed to misoprostol in utero a number of congenital Drugs – Actions, Interactions
malformations but not Mobius' syndrome were noted. Goldberg in her reviewarticle on misoprostol (Goldberg, Greenberg et al. 2001) reviews the literature oncongenital malformations in infants exposed to misoprostol.
Model Process for
First Trimester Medical Abortions
Model Process for First Trimester Medical Abortions
This process is based on that developed and used in the Level J Unit, WellingtonHospital. The roles are those used by that clinic and may be variously interchangedbetween appropriately qualified staff.
This model process deals with clinical procedures. The legal requirements must bemet before the clinical process is applied but are not referred to in this document.
The referring doctor should counsel the patient about the option of medical abortionfor early pregnancies – see Client profile below.
The doctor should provide written patient information on medical abortion options(for sample see Appendix 6).
All usual clinic referral requirements should be fulfilled. This includes full medicalhistory, exclusion of ectopic pregnancy, infection screen and antenatal bloods.
The referring doctor must accurately assess the gestation by history and clinicalassessment including routine ultrasound assessment. Transvaginal ultrasonographyshould be requested but should be delayed until 35 days amenorrhoea or serum βhCG>2000.
If the patient is considering medical abortion, she should receive a clinic appointmentas soon as possible to ensure the medical abortion can be given before 63 days oraccording to the clinic protocol.
• Women with pregnancy <9 weeks (63 days) amenorrhoea at time of mifepristone • Intra-uterine pregnancy confirmed by U/S scan• There are no medical contraindications (see 5.5 above)• Social contraindications: o Indecision about having an abortiono Unwillingness to have a surgical abortion if medical abortion failso Lack of direct telephone access, e.g. phone not toll-barred if the woman lives away from the clinic area o Is unable to cope with the likely pain and bleeding or lacks the support she o Does not have the ability to identify problems and know how to act on themo Transport problems (for return visits and in the event of an emergency)o Inability to communicate on telephone or to have support person who speaks o Lives more than two hours' travelling time from the clinic or hospital.
First clinic visit – Day 1
Model Process for
First Trimester Medical Abortions
6.3.1 Counselling
(For more detail on counselling, see also Section 9, Counselling for Medical
Abortion.)
• Options-counselling as per usual. This may be been done at an outreach clinic.
• If women fit the client profile for medical abortion discuss medical abortion as an
alternative to surgical abortion.
• Discuss the advantages of early medical abortion. For example, medical abortion is non-invasive, it avoids surgical and anaesthetic risk and can occur very early inpregnancy, it has been perceived by many patients to be more natural, and it allowsmore privacy and control. Give information about the advantages of early surgicalabortion.
• Review adverse effects: bleeding and cramping (usually heavier than with menses) are to be expected; diarrhoea and other gastrointestinal side effects are common;there is a longer duration of bleeding than after surgical abortion; there is a verysmall risk of prolonged or heavy bleeding requiring a vacuum aspiration surgicalprocedure. (The adverse effects can be discussed more fully with the medical ornursing staff, as will be the instructions on what to do in an emergency.) • Explain to the patient the three-visit procedure (mifepristone, misoprostol and follow-up to ensure completion) and the need to adhere to the protocol. If theabortion is unsuccessful, a surgical abortion must be performed due to the possibleteratogenicity of misoprostol. Ensure that she agrees and is able to return for thethree-visit procedure.
• Ensure that the woman is clear about her decision to have an abortion and fits the client profile (see 6.2).
• Give information about the process and the drugs used.
• Offer culturally appropriate assistance, e.g. a Maori health unit, and the provision of an interpreter if necessary.
• Discuss contraceptive options and give information.
6.3.2 Medical assessment
(This may be done by one doctor, if first certification has already been provided, or, as
in Level J Unit, divided between two certifying doctors.)
• Check information provided by referring doctor and results of all tests performed.
• Obtain a medical history and check adequate dating of the pregnancy.
• Bimanual examination is advised to exclude adnexal pathology.
• Review of ultrasound examination results is recommended to assess any possibility
of ectopic pregnancy. Ultrasound examination cannot completely exclude thepresence of an ectopic pregnancy and if there are clinical grounds for suspectingectopic pregnancy, serum ßhCG estimations should be performed. (Identification ofintrauterine sac can be expected on transvaginal ultrasonography with βhCG>2000.) • Rule out contraindications to medical abortion – see 5.5 Medical contraindications and 6.2 Client profile.
• Ensure treatment of any infection.
Model Process for
First Trimester Medical Abortions
• Review plans for post-abortion contraception: o Patients who choose oral contraceptives may take the first pill the day after the completion of their abortion o Depo Provera can be given after completion of the abortiono Patients may begin to have sexual intercourse with barrier contraception when they have stopped bleeding o Patients who choose sterilisation should be referred as appropriate to avoid delays, and interim contraception should be put in place o IUCD may be inserted one week after proven completion of the termination.
• Review the patient consent form, which takes into account the Istar-Exelgyn agreement as well as evidence-based changes in the protocol for mifepristone andmisoprostol and consent for Anti-D if indicated. The patient is to sign and date theform and the medical assessor is to sign as witness (see 4.3.6 and Appendix 3 forsample consent). o Anti-D if indicatedo Mifepristone 200 mg p.o., misoprostol 800 mcg p.v. initial dose and a second dose of 400 mcg after 4 hours if delivery of products not imminent.
o Pain relief and anti-emetics for Day 2.
6.3.3 Nurse/midwife care
Some of the above assessment may be carried out by a nurse/midwife. In particular,
the patient may feel more comfortable when the nurse gives information on what to
expect in the way of pain and bleeding, provides education on what is regarded as
normal, and discusses practical details such as use of pads/tampons/bedpans and when
to ring the emergency number. The patient should be given written information on
how to call that number.
6.3.4 Administration of the treatment
• Administer Anti-D if indicated.
• Administer mifepristone 200 mg tablet by mouth. Keep patient under
medical/nursing observation for one hour to ensure there is no reaction to the drugand that it has been ingested. (Legal requirement – mifepristone must beadministered under the responsibility and control of the prescribing doctor, in thepresence of the doctor or a health professional, and on the licensed premises.) • Give the patient written instructions.
6.3.5 Support for patient at home during interval between mifepristone and
misoprostol
• Make sure the patient knows how to reach provider on-call. The patient
information sheet should include instructions about how to call or page theprovider, and the information should be reviewed to be sure she understands.
• If the patient experiences significant pain or bleeding she may need earlier admission. 50% will experience some bleeding and 2-5% of patients will completethe abortion within 48 hours after the mifepristone.
Model Process for
First Trimester Medical Abortions
• On-call provider(s) should use triage assessment guides (see Appendix 4 for sample) and be clear about when and where to refer any problems Second clinic visit – Day 2
In the normal course of events, if no symptoms have caused the client to come inearly, she will be re-admitted to the clinic in the morning 36-48 hours followingmifepristone administration. (Legal requirement – misoprostol must be administeredunder the responsibility and control of the prescribing doctor, in the presence of thedoctor or a health professional, and on the licensed premises.) 6.4.1 Discharge home immediately after misoprostol administration
Ensure the woman has information about what to expect, supplies of analgesia which
may be needed, and information on when and how to obtain assistance.
These patients will need a 24-hour telephone number to contact for advice on
management of pain, bleeding and any unexpected side effects. The health
professional must be familiar with management of early medical abortion and have
clear written protocols to follow in giving advice. Language may be a problem. Back-
up access to emergency gynaecological services must be available if problems occur
and the patient requires admission.
6.4.2 Patient remaining in clinic after misoprostol administration
Management of the patient for the second day can be done entirely by an experienced
nurse/midwife who will:
• Ensure that all administrative procedures are complete
• Take temperature, pulse and blood pressure base-line recordings then hourly until
• Perform vaginal examination and insert misoprostol 800 mcg into the posterior • Make the client comfortable and await events.
Over the next 4-6 hours the nurse/midwife will:• Inspect all body fluids passed for products of conception (use disposable bedpans)• Administer comfort measures and analgesia as required by patient• Offer a regular diet until contractions commence then fluids only.
Once products have been passed, the client is rested, given a light diet and dischargedhome.
The woman must be given clear instructions on how and who to contact for advice onpost-abortion complications and access to emergency gynaecological services in theevent of severe complications after discharge.
Model Process for
First Trimester Medical Abortions
6.4.3 Analgesia
Encourage non-pharmaceutical pain management strategies (see Section 4.7).
Offer simple analgesia and/or anti-emetic routinely before the misoprostol insertion
and repeat as required.
Medications will need to have been charted by a doctor according to clinic protocol
(see Section 4.7 for discussion of options).
6.4.4 Possible complications
Fever: Temp >38°C for >1 hour – arrange blood culture and give antibiotic therapy.
Haemorrhage: Medical assessment if more than 2 maxipads per hour for 2 hours.
Post-abortion bleeding: This may go on for much longer than with surgical TOP but
if the patient is soaking a pad per hour for more than 10-12 hours or exhibiting signs
or symptoms of hypovolaemia, medical assessment is needed.
Allergic reaction to any of the medications.
6.4.5 Failure to complete under clinic observation
Clinics may choose to offer support for a limited period or the patient may go home
immediately after misoprostol administration (see 6.1 above)
Discharge home after 4-6 hours in the clinic:
• 5 - 10% of patients may fail to pass the conceptus within 6 hours.
• Before discharge, the doctor or nurse/midwife can perform a vaginal speculum
examination to check that products are not sitting in the vagina or cervix and caneasily be removed.
• The patient can be discharged to complete the termination at home. However she requires access to telephone support and advice for the management of symptoms(pain and bleeding) she is likely to experience at the time of completion of theabortion (see 4.4.3 above).
• The woman must be given clear instructions on how and who to contact for advice on post-abortion complications and access to emergency gynaecological services inthe event of severe complications after discharge.
Final medical consultation to ensure abortion is complete
A further visit is mandatory in 10 – 14 days to ensure the abortion is complete andthere are no complications with bleeding or infection.
The patient will have already signed consent to this taking place.
This follow-up visit can be provided by the clinic or by the referring doctor. Referringdoctors will need continuing medical education and adequate information aboutmanagement of patients after medical abortion.
If the referring doctor is to do the follow-up, the clinic providing the abortion shouldappoint a designated health professional from its staff to keep a record of each patientand ensure follow-up has taken place before the patient file is closed off. A staffmember should phone the referring doctor if information is not forthcoming.
Evidence of no on-going pregnancy: see 4.5 above.
Premises and Facilities
Premises and Facilities
In the clinic
• Abortion facilities must comply with the requirements of section 21 of the Contraception, Sterilisation, and Abortion Act 1977.
• All current licensed institutions have facilities for performing surgical abortion, although surgical procedure rooms are not needed for early medical abortion.
• There is a statutory requirement under the CS & A Act for all institutions providing abortion to have access to overnight-stay facilities (s.21(1)(a) or s.21(2)(c)).These apply irrespective of whether medical or surgical abortions areperformed.
• Current published literature supports the safe and effective practice of medical abortion in diverse settings (Mackenzie and Yeo 1997; Breitbart, Rogers et al.
2000), ranging from hospital-based (Ashok, Templeton et al. 2002) andfreestanding clinics (Spitz, Bardin et al. 1998; Schaff, Eisinger et al. 1999) to solopractitioners' offices (Hausknecht 1995).
• Hospitals that have an abortion licence could develop early medical abortion facilities separate from the surgical facility. For patients who remain in the clinicuntil the abortion for up to 8 hours, accommodation in a set-up similar to thesingle recovery rooms for surgical abortion is appropriate.
• Day 1 of the early medical abortion process requires similar facilities to pre- abortion assessment of surgical patients. Patients given mifepristone can remainambulatory.
• RCOG guidelines (RCOG 2000) recommend the privacy of single rooms for all women having medical abortions for the misoprostol induction.
• It is in the interests of all women and their support people to separate women undergoing abortion – for whatever reason – from women whose pregnancies arebeing preserved, birthing or post-natal women, and babies.
• Facilities can be combined for spontaneous pregnancy loss and induced abortion for any reasons: emotional, physical reasons and fetal anomaly. Many UK unitshave such integrated services. Consumer consultation would be appropriate beforeany change is introduced here.
• There is an advantage in women keeping upright and active during the labour process. However after narcotic analgesia, women need to be able to lie down, anddifferences in pain levels and coping ability mean that some women prefer to berecumbent. Many overseas clinics manage women in a sitting-room environment.
• Access to toilets is crucial – ensuite is ideal. Disposable bedpans need to be put into toilets so that products can be viewed.
• Hot water bottles, heat pads and cold packs are first line pain relief and comfort • Housekeeping and infection control need to be managed because of the copious blood loss. Squeeze bottles with chlorine for toilets are useful.
Premises and Facilities
• Increased publicity at the time of introducing a medical abortion service may increase threats from protestors and it would be timely to review the unit'ssecurity provisions.
Part of the assessment for women wanting to go home to abort after misoprostoladministration is of physical facilities – access to toilet, shower/bath, and laundryfacilities. Also (see 4.4.3) support, access to a telephone, transport, supplies of painrelief and pads, etc.
Easy access to ultrasound scanning with vaginal probe is essential for provision ofmedical abortion.
It is a highly recommended part of international guidelines and clinical protocols thata transvaginal ultrasound scan (USS) is performed before an early medicaltermination. This ensures that an intrauterine embryonic sac with a fetal pole has beenrecognised. If this has not been recognised, it helps to point further management andfollow-up in the right direction.
Ultrasound does not necessarily have to be performed in the unit providing themedical abortion. However, it is extremely difficult to guarantee urgent access toscanning if the service has to compete for the variable access provided in privatehospitals or with the overloaded obstetric/gynaecological ultrasound scanningdepartments in the public hospitals. It would be wise for the large units to have theirown ultrasound scanning services on site.
As well as pre-abortion routine USS, access to scanning during the procedure ensuresa safe clinical service. Women who bleed heavily after mifepristone, for whom thereis doubt about whether they have already aborted, may need to be re-scanned beforemisoprostol administration. This is not uncommon as up to 5% of the women willcomplete their abortions after mifepristone alone, and 50% will have some bleeding inthis period.
To help determine the appropriate management, further ultrasound assessment may beneeded at any stage of the procedure if pain or haemorrhage occurs.
It is essential to incorporate risk management and limitation strategies at the outsetwhen establishing any new procedure, and easy access to ultrasound services is part ofthis for medical abortion.
• Clear, accurate, user-friendly written information must be available for clients at all stages – pre-decision, pre-procedure, post-procedure (see Appendix 6 for examplesof pamphlets).
• Information should be available in languages other than English to meet the needs of the client base.
• Information for referring doctors is particularly useful to enable early referral (see Appendix 7).
Staffing and Staff Training
Staffing and Staff Training
Planning for the introduction of medical abortion requires a general assessment ofstaff levels and training. Appendix 5 is "A general guide for initiation of medicalabortion services", adapted from Breitbart, Rogers and VanDerhei, which provides auseful review of issues to be considered.
Administrators, receptionists, counsellors, nurse/midwives and medical andhousekeeping staff in an abortion clinic are all involved directly or indirectly in everyaspect of the medical abortion process.
As only licensed clinics (for surgical procedures) can provide medical abortion, unlessthere is a change in the regulations, early medical abortion will usually beincorporated into existing surgical facilities. Hospitals that have an abortion licencecould develop an independent early medical abortion service separately.
Clinic staffing requirements will differ only slightly from those required for surgicaltermination. The time required for counselling and assessment for medical abortionmay be greater initially, but this should decrease as all staff become familiar withincorporating medical abortion advice into their routines. Once the decision formedical abortion is made and informed consent obtained, it is advisable that thewoman remains in the clinic for up to an hour after the administration of mifepristone,but little supervision is usually required in this time unless there is vomiting or someother complication.
When the patient returns for the misoprostol administration, if the patients remain inthe clinic, staff levels are similar to those required for pre-and post-operative surgicalcare, without the need for theatre staff.
Level J Unit, Wellington, staffs its abortion unit with approximately onenurse/midwife and one coordinator to 4 patients. This number appears appropriate formedical or peri-operative surgical patients. A small proportion of patients may requirea longer time on the premises, e.g. up to 8 hours.
Staff hours required for provision of a second trimester abortion service will besignificantly less than those for an induction of labour without mifepristone becauseof the reduced time interval between misoprostol administration and delivery.
There are few studies of provider acceptability of medical abortion. Winikoff(Winikoff 1995) reviewed some early studies that we have not been able to obtain.
Marwick (Marwick 1994), in a report on nurses in Aberdeen, apparently suggestedthat the introduction of medical abortion to a clinic already providing surgicalabortion can alter job satisfaction because of adjustments in tasks. The reportsuggested that providers should allow staff to redistribute their functions so that thosewho prefer to be more (or less) involved with medical abortion patients can seeksuitable assignments. This is probably even more relevant in a service providingsecond trimester abortions.
Role of nurse/midwife
Staffing and Staff Training
(McKee and Adams 1994; Timpson 1996; White 1996; Mackenzie and Yeo 1997;Narrigan 1998; Murphy, Jordan et al. 2000; Williams 2000).
After medical assessment, legal certification and charting of medication are complete,the clinical care of women undergoing both early and late medical abortion is likely tobe in the hands of nurses and midwives, with clear guidelines for contact points withmedical staff identified in the written protocols.
• The additional responsibility that nurses and midwives may assume in the provision of medical abortion may be seen as an exciting professionaldevelopment and should be appreciated and exercised by the professionals and byservice providers.
• Even within a dedicated abortion service, where staff have chosen to be employed, they need to have a choice about how they are involved in abortion of advancedpregnancies.
• Integrated units, where women undergo abortion on all legal grounds at all gestations, staffed by nurses/midwives who are choosing to do this work, areanecdotally reported (UK/NZ) to have clear advantages in the areas of job andclient satisfaction.
Staff training for medical abortion
8.4.1 Introduction
• Staff orientation and training for medical abortion should involve all the personnel
in the clinic as well as the referring doctors and the agencies in which they work.
• All staff must be committed to the process of providing medical abortion.
• The level of training required depends on the actual role they fulfil, but all staff should learn the appropriate way of interacting with a patient at each stage of theprocedure.
• A multi-disciplinary process is in the best interests of clients and all staff working in the area of medical abortion.
• Counselling to enable the woman to make a fully informed decision and to cope with her feelings, reactions and any social impact may be offered by differenthealth professionals: counsellors, social workers, psychotherapists, nurse-midwives and doctors depending on the local arrangements. All healthprofessionals who counsel women need specific training in abortion counselling.
Women may need referral to professional mental health services.
• Staff development, support and debrief needs should be readily met as required or requested by staff. It is desirable to provide professional supervision for all healthprofessionals working in the area of abortion.
• Exploration of the health professional's own value system and honesty about personal issues and beliefs that might influence client management is alwaysadvisable in abortion service provision (McKee and Adams 1994; Timpson 1996;Narrigan 1998; Williams 2000). • Processes for audit and on-going review of the service should be introduced from • The assessment and management of potential complications of medical abortion should be reviewed periodically within each institution.
Staffing and Staff Training
• Anticipating possible increased media attention at the time of establishing a medical abortion service is important and discussions may be held withcommunications/public relations staff.
• An on-line training program on early medical abortion is available free through the US National Abortion Federation at www.EarlyOptions.org.
8.4.2 Training for referring agencies
Referring doctors need to take responsibility for keeping up-to-date with
developments in abortion provision. However clinics that introduce medical abortion
services would be wise to provide best practice information for their referrers, to
ensure early and appropriate referral and that the clinic's requirements for referral are
met. (See Appendix 6, Pamphlets on Early Medical Abortion, and Appendix 7, Guide
for Referring Agencies.)
8.4.3 Administrative staff
Administrative staff in the offices of referring practitioners and in clinics (e.g. family
planning clinics) should be trained to offer timely information to women so that early
medical abortion can be an option.
Administrative staff in abortion clinics need training to ensure that appointment
systems are managed to enable counselling and medical assessment appointments to
be offered as soon as possible after referral. Understanding the advantages of having
procedures take place at the earliest possible gestation will improve staff performance
in this respect.
8.4.4 Training for counsellors
Those engaged in abortion counselling need to be familiar with the requirements
outlined in the Abortion Supervisory Committee's Standards of Practice for the
Provision of Counselling publication, and should have regular supervision/peer review
for their professional practice. Specific training in the process of medical abortion
using mifepristone and misoprostol is advisable to familiarise health professionals
providing counselling with the physiological, logistical and psychosocial aspects of
the procedure.
Counsellors need to be knowledgeable about the need for all women (including those
in the second trimester) to discuss their options, and to be adequately informed about
the stage of development of the fetus and the procedure, their feelings and beliefs
about abortion and their pregnancy, and their possible feelings following abortion.
Counsellors should recognise that women facing the choice of abortion for fetal
anomaly also need access to specialised genetic counselling, and that there are
particular grief issues arising from facing abortion of a wanted pregnancy.
Counselling training should also include post-abortion counselling.
Counsellors must be non-judgemental and qualified to assess the needs and the coping
mechanisms of women facing abortion for any reason.
Counsellor training for early medical abortion will require familiarisation with the
literature from other countries on the physical, emotional and social aspects and the
consumer satisfaction evidence. Visual aids (for example laminated comparison
charts) are useful to support discussion on the relative advantages and disadvantages
of early medical and early surgical abortion and stages of pregnancy development.
For all counselling training requirements contact the Abortion Supervisory Committee's Regional Counselling Advisor Staffing and Staff Training
8.4.5 Medical staff training
Clinical leaders must ensure background literature and detailed protocols are available
for all medical staff. Depending on the prior knowledge of medical staff, appropriate
staff training should take place before early medical abortion is offered.
Peer review is important, particularly over the first few months when units report a
"steep learning curve" for all staff.
8.4.6 Nurse/midwife training
A midwifery perspective is relevant in the care of women undergoing medical
abortion – particularly mid-trimester – though care can be in the hands of adequately
trained and supervised registered nurses (White 1996; Albers 1998).
Managers and nurse/midwife leaders must ensure that adequate education and regular
professional supervision to enable review of practice and debrief mechanisms are
readily available.
Training for nurse/midwife staff needs to incorporate physical, mental, emotional,
cultural and spiritual aspects of abortion care. Also needed are basic counselling
skills, including an understanding of the need for clear boundaries and mechanisms
for debriefing and reviewing practice (Timpson 1996; White 1996; Mackenzie and
Yeo 1997; Murphy, Jordan et al. 2000; Williams 2000). Up-to-date knowledge of
contraceptive methods is essential as this forms part of every woman's discharge plan.
On-call staff should receive training in telephone assessment and decision making to
ensure support and advice are readily available to women who are at home during
parts of the medical abortion process. Standard on-call assessment guides and record
sheets must be used to ensure consistency in dealing with calls and clear, acute
documentation of the issues.
In both UK and US clinics, routine ultrasound examination, pelvic examination and
routine swabs and bloods are all performed by trained nurse/midwife staff. Training
will be required in those areas delegated to nurse/midwife staff in New Zealand
clinics.
Registered nurses will require training in vaginal examination to enable the
administration of misoprostol by the vaginal route. This needs to include teaching
women how to self-administer vaginal misoprostol.
8.4.7 Training for specialist services
Before any medical abortion services are offered, clinics must ensure the availability
of specialist gynaecological services for referral of any complications.
While it is clearly not the responsibility of an abortion clinic to train specialist medical
staff, it might be wise to offer clinical information, appropriate medical literature, and
combined training.
8.4.8 Training for second trimester services
The gestation of the woman might have an influence on which staff are suitable and
willing to care for women undergoing second trimester abortions.
Second trimester services, in particular, put significant psychological stresses on staff
and this must be acknowledged and provided for.
Because women having second trimester abortion are usually significantly more
emotionally stressed, training for their management must include understanding of the
reasons for women requiring second trimester abortions and how to support the
women through the process.
Staffing and Staff Training
It is in the best interests of the women to have staff who are not ambivalent about theirown commitment to abortion provision.
Nurse/midwife staff who provide care must be trained in the management of labourand birth and be able to inform women about after-care, including breast care (Albers1998).
Counselling for Medical Abortion
Counselling for Medical Abortion
The counsellor's role is to discuss pregnancy options, to ensure that the decision tohave an abortion is informed, voluntary and non-coerced and the patient understandsthe possible effects on her of the decision she makes.
The decision on the abortion should be made before discussing the methods ofabortion available. The decision to terminate is generally independent of the methodsof abortion available, although less so at greater gestational ages.
Giving information on methods, and assisting the patient to make choices where thisis possible, may be done by counsellors, nurse/midwives or doctors, depending on thearrangement in the particular clinic.
The client's choice of method of abortion is likely to be determined by medical andpsychosocial factors.
The advantages and disadvantages of medical abortion need to be outlined. The alternatives should be discussed, such as the availability and risks of earlysurgical abortion in early pregnancies and alternatives in late pregnancy depending onwhat can be offered in the particular clinic.
The importance of adherence to protocol needs to be emphasised and the possibility ofeffects on the fetus if the pregnancy is left to continue after the drugs have been taken.
Explain to the patient the three-visit procedure (mifepristone, misoprostol and follow-up to ensure completion) and the need for consent to alternative procedures if medicalabortion fails. Clarify that she would be able to return for all visits.
Both first and second trimester medical abortion should contain the standard contentof pregnancy counselling as specified in the Abortion Supervisory Committee'sStandards of Practice for the Provision of Counselling. At times counselling and assessment may be more intensive than for surgical abortion.
This is because it will involve not just a focus on the classical abortion conflicts(socio-cultural, socio-economic, internal-emotional, interpersonal, moral, ethical,religious issues, etc.). It will also, if a first trimester abortion is sought, involve theclient's choice between two methods of treatment, and the information on them thatshe will need in order to make that decision.
Experience overseas shows that – depending on the needs of the individual woman –counselling takes less time as staff become more familiar and comfortable withoffering the procedure.
The following factors should be assessed:• Transport. The client must have reliable transport (use of vehicle and driver) for return visits and in the event of an emergency.
• Communication. Unless there are appropriate multi-lingual staff available in the clinic or on the 24-hour telephone line, the client must have adequate English tounderstand instructions and be understood by telephone or have a support personalways available who is able to communicate in English. Twenty-four a day directtelephone access is required. She must be able to call a mobile phone from hertelephone.
Counselling for Medical Abortion
• Childcare. The client must have pre-arranged childcare. It must cover emergency childcare needs (e.g. middle of the night) as well as at the times of scheduledappointments.
• Confidentiality. Some clients wish to tell no one of their abortion. However, the client ideally should have at least one appropriate, accessible person who is awarethat she is undergoing this procedure and is able to provide emotional and practicalsupport.
• Proximity. The client needs to live or be accommodated within an hour's drive from the clinic or emergency hospital facilities.
The woman's chosen support, whether it is partner or other, needs to have asupportive view of the TOP and the emotional ability to support the woman throughthe process. If the clinic permits the presence of a support person, ensure that theperson does not pose a threat to staff or clients. There is no contraindication formedical abortion if the woman is going to be on her own. Practical support – the woman ideally has someone to provide transport and to staywith her overnight.
Psychological and emotional factors
The client must have the ability to cope psychologically and emotionally with themedical abortion process.
The counsellor needs to:• Assess those issues that may affect the client's ability to manage the abortion e.g. a history of anxiety, sexual abuse and other issues. Medical abortion may be moreappropriate for such people than a surgical procedure, but assessment of copingskills is needed.
• Discuss the client's comfort level regarding the process involved in medical abortion. Is she able to deal with cramps, bleeding and possibly delivering thepregnancy tissue at home? Second trimester abortions
For second trimester pregnancy counselling there are particular issues that may needaddressing:• Reasons for late presentation, e.g. ambivalence, denial of the pregnancy• Ambivalence may be related to lack of support, or pressure from partner or family to continue or to abort the pregnancy.
• Fetal development, fetal movement• Viewing the fetal tissue. This is much more difficult to avoid because of the later stage of pregnancy. It may be beneficial for the client's mental health long term ifshe feels able to view the tissue. However it is not desirable to force this upon theclient.
• Fetal anomaly issues require referral to specialist genetic counselling for future Counselling for Medical Abortion
• The importance of having a post mortem examination when there is fetal anomaly should be discussed. This issue should be raised by the maternal-fetal medicineconsultant or obstetrician and may also raised by the midwife, genetic counsellorand/or the health professional providing pre-decision counselling. Written as wellas verbal information is ideal. Balance must be achieved between the time parentswish to spend with their fetus/baby and the clinical/system requirements for postmortem examination. Follow-up discussion of the results will generally be arrangedwith the consultant. It can be useful to schedule a post-abortion counselling sessionto be available soon after this to assist patients to process the information as well aswith grieving and achieving closure.
• Level of attachment to the pregnancy• Other life traumas or grief issues may be part of their situation. For example, late presentation for abortion may be due to the end of the relationship, the death of animportant support person or some other life crisis • Value system – moral, ethical, religious and spiritual issues• Assessment of risk of post-abortion mental health problems is crucial and the possible impact of the decision to abort must be discussed • Coping afterwards – level of support and coping strategies.
Other issues
Ability to commit to the medical abortion process is important. The client mustcommit herself to follow up if she does not deliver within the three-visit time frame.
Non-delivery in the three-day time frame may create problems for her in terms ofsafety or confidentiality or may create other issues.
Explore the client's own pregnancy history. Previous negative experience of TOP maybecome a significant counselling issue, as well as part of assessment.
The client must have a contingency plan in place to ensure that she receivesappropriate support and has the ability to make return visits during the medicalabortion process.
Offer culturally appropriate assistance, e.g. Maori health unit, and the provision of aninterpreter if necessary. Keep in mind that a client's inability to speak English may bea barrier to undergoing early medical abortion.
Discuss contraceptive options and give information.
Management of Fetal Tissue
10.Management of Fetal Tissue
Women must be realistically informed about the appearance of pregnancy tissue at
different gestations.
All clinics must have a policy in place for disposal of pregnancy tissue. This will be
similar to that required for surgical abortion. There are legal, cultural, spiritual,
ethical, staff training and infection control issues that need to be addressed in the
policy.
There is a legal requirement for notification of the birth to the Registrar of Births
Deaths and Marriages if the pregnancy is over 20 weeks' gestation or the fetus is over
400 gm in weight.
Maori clients may have particular wishes regarding the fetus or placenta/whenua.
Medical and legal terminology can distress or offend women. When discussing the
pregnancy products with clients, health professionals need to take the lead from the
woman, who might wish to refer to her "baby" regardless of gestation.
User-friendly written and verbal information needs to be available to women from the
first visit about their rights with regard to their pregnancy tissue. It should state:
• the policy of the clinic with regard to management of the tissue and any options
that the clinic provides, such as paying for cremation through private funeraldirectors • the method and site(s) of disposal if the woman does not wish to take home her pregnancy tissue.
• her obligations if she does choose to take home the tissue.
Staff must be aware of the policy, their responsibilities, and the need for respect anddignity in the management of pregnancy tissue. They must have sensitivity towardswomen and their individual beliefs and needs with regard to their pregnancy tissue.
For women who abort at home discussion is required on disposal of tissue. Manywomen will not see products of conception because they are small and passed alongwith heavy blood loss. If fetal tissue is identified women may choose to deal with it asabove.
When termination has been performed for fetal anomaly it is important to attempt toprovide confirmation of the fetal abnormality after delivery, preferably by post-mortem or histology. If there is not consent for post-mortem or histology, a secondbest option should be recommended such as ultrasound. The nursing/midwifery staffmanaging care during the procedure will have to know and understand the pathologyrequirements and be adequately prepared to discuss these sensitively and realisticallywith the woman and her support person(s). Appendix 9 is the Level J Unit client information on management of pregnancy tissue.
Evaluation and Audit
Evaluation and Audit
11.1 Audit in the clinic
Each clinic should establish procedures for review of their medical abortion service.
This should include procedures for assessing client satisfaction as well as reviewing
how the service is working from the staff perspective.
Designated staff should maintain records of any complications and any critical
incidents. These data should be analysed periodically to discover trends.
Some clinics are already accredited by outside agencies and this is to be encouraged.
The Abortion Supervisory Committee is looking at ways of collecting and analysing
data on medical abortion and we can expect some outcome from this by 1 January
2005.
11.2 National audit
There is a need for New Zealand data on medical abortion. It cannot be assumed that
data collected in other cultures are entirely relevant to New Zealand.
Istar Limited is offering to audit Mifegyne use in New Zealand and would greatly
appreciate clinics providing non-identifiable information about each abortion. The
company is offering to collate and provide up-to-date analysis of any data that are
provided.
The company can provide an Access file for information to be collected or an audit
form.
11.3 Abortion Supervisory Committee
The Committee collects routine information on abortions through the ASC4 form.
This form is legally required and is compulsory for providers to return. The
Committee will consider appropriate modifications in line with this new service.
These guidelines are designed for services that wish to establish or extend the
provision of medical abortion and to offer to women in New Zealand choices that
have been available for many years in other parts of the world.
All papers on the reference list are available via medical libraries and are held by the
Abortion Supervisory Committee.
Electronic resources are numerous and the public are already active in obtaining
information about abortion via the Internet. Much of this is negative anti-abortion
material that needs to be balanced by evidence-based, objective information.
Useful sites include:
www.prochoiceforum.org.uk
www.rcog.org.uk
www.earlyoptions.org
www.plannedparenthood.org
www.gynpages.com
www.cliniciansforchoice.org
New Zealand abortion providers should be encouraged to develop local websites.
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Source: http://abortionservices.org.nz/docs/ASC_Technical_Committee_Report_24_Aug04.pdf