Background
Pre-abortion assessment and appropriate decisionmaking
is imperative for the success of a safe medical abortion programme.
Clinicians caring for women requesting abortion should try to identify
those patients who require more support in decision-making than
can be provided in the routine clinical setting. Facilities for
additional support, including access to social services, should
be available. Initial steps in providing preabortion care are designed
to establish that the woman is pregnant, pregnancy is intrauterine
and to determine the length of pregnancy.
QUESTIONS TO BE ANSWERED
The group needed to decide on
- What should be the cut-off gestational
age limit for medical termination of pregnancy by medical methods?
- What is the importance of history-taking
and examination?
- What minimum investigations are mandatory?
- What pre-abortion counseling should be done?
VIEWS OF THE GROUP
The group focussed on the pre-abortion assessment including the cut
off gestational age, essential historytaking
and examination, contra-indications and the role of pre-abortion counselling.
A.
A. Period of Gestation
The legal age limit for termination of pregnancy according to MTP
Act of India (1971) is permitted up to 20 weeks of gestation.
The expert group meeting held in October, 2002 suggested approval
for use of medical abortion in India till 8 weeks of pregnancy (up
to 56 days amenorrhoea from the first day of the last menstrual
period). However, currently its use is recommended up to 7 weeks
(49 days of amenorrhoea). Earlier is the pregnancy at the time of
an abortion, lower is the risk of complications.
As gestational age increases, the efficacy decreases and rate
of complications increase, specially in terms of more bleeding days.
B.
Clinical History and Examination
Various components to be evaluated.
| Efficacy
of Medical Abortion: A Meta Analysis |
Multiple clinical studies
demonstrate the efficacy of medical abortion with mifepristone
or methotrexate followed by a PG analogue. However, assessing
predictors of success, including regimen, is difficult because
of regimen variability and a lack of direct comparisons. A
meta-analysis was performed using 54 studies published between
1991 and 1998; data abstracted included regimen details and
clinical outcomes by gestational age. It was found
that efficacy decreases with increasing gestational age and
differences by regimen are not statistically significant except
at gestational age > 57days. For gestations < 49 days,
mean rates of complete abortion were 94-96%, incomplete abortion
2-4% and ongoing (viable pregnancy) 1-3%. For gestation of
50-56 days, the mean rate of complete abortion was 91%, incomplete
5-8% and ongoing pregnancy 3-5%.
Thus, both mifepristone and methotrexate, when administered
with misoprostol, have high levels of success at < 49days
but may have lower efficacy at longer gestation.
Second trimester pregnancy termination (13-20 weeks) studies
have been conducted using mifepristone and misoprostol combination.
Results have indicated 80% complete abortion within 12-24
hours and 94% within 24- 48 hours. Although mifepristone and
misoprostol have not been licensed for induction of abortion
in midtrimester pregnancy, experience is accumulating by off-license
use that it is effective and safe. Mid trimester termination
should be certified by at least 2 registered medical practitioners.
Patient should be hospitalized in a
place well-equipped with evacuation and blood bank facilities
and 24-hour emergency services.
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(i) Gynaecological History
- Dating of pregnancy by LMP should be done and enquiry regarding
the previous menstrual history made including duration and flow
- Ectopic pregnancy must be excluded
- If IUD is in situ, it must be removed before giving mifepristone.
If patient is on oral pills, post-pill amenorrhoea should be ruled
out. In such cases, diagnosis of pregnancy is very essential
- In patients with history suggestive of fibroid uterus, close
supervision is required
- Previous scarred uterus (myomectomy, caesarean and hysterotomy)
also warrants caution, although it is not a contraindication for
medical abortion
- Mothers who are breast-feeding should omit feeding on the day
of administration of drug
- If history suggests active vaginal infection, it should be
treated. One should ask regarding excessive/purulent/ offensive
vaginal discharge.
(ii) Medical History
History should be elicited to exclude contraindications to mifepristone
and misoprostol. Medical contraindications are as follows:
History suggestive of
- Chronic adrenal failure
- Uncontrolled hypertension
- Cardiovascular disease
- Anaemia (Hb < 8 gm %)
- Severe liver, renal or respiratory
disease
- Known coagulopathy or on anticoagulants
- Drug history (women on aspirin,
steroids and antidepressants)
- History of intolerance or allergy
to drugs especially mifepristone and misoprostol
- Uncontrolled seizure disorder
(iii) Social and Psychological History
Medical abortion is not advised for women
- Unreliable to take responsibility
- Unable to comprehend
- Unable to come for follow-up
(iv) Examination
- General physical examination to rule out anaemia and active jaundice
- Measurement of vital parameters (pulse, BP, Temperature, RR)
- Systemic examination
- Gynaecological examination (per speculum, bimanual) to confirm
pregnancy and determine the size of uterus. If uterine size is smaller
than expected, missed abortion or ectopic pregnancy should be excluded.
If uterine size is larger than expected, one must rule out multiple
pregnancy, fibroid or a molar pregnancy. Screening for RTIs should
be done. If there are clinical signs of infection, the woman should
be treated immediately with antibiotics and abortion can then be carried
out.
C.
Investigations
Pre-abortion assessment should include
(i) Measurement of haemoglobin to rule out anaemia.
It should be at least 8 gm% in Indian settings
(ii) Tests for ABO and Rhesus (Rh) blood group
typing should be provided where feasible, especially at higher level
referral centres. It is a must in primigravidae. If a woman is Rh
negative, Rh immunoglobulin should be given on the same day as mifepristone
administration
(iii) Pregnancy Test
- Urine examination for pregnancy test is to be done in all cases
undergoing medical abortion, especially if the patient is lactating
or having irregular cycles and not sure of pregnancy. It should
be done in all cases with pregnancy less than 6 weeks so that amenorrhoeic
women with delayed periods who are not pregnant do not take the
drug. Clinical examination for diagnosis of early pregnancy is difficult
even in the best of hands. Measurement of urine HCG can detect pregnancy
as early as 7 days after implantation (sensitivity 25 MIU/ml) in
98% of cases and 2 days before missed period (sensitivity 50 m IU/
ml) in 90% cases respectively. These tests are based on detection
of monoclonal antibodies against subunit of HCG.
(iv) Ultrasound- Ultrasound
scanning is not necessary for the provision of early abortion in
all cases (RCOG 2000). However, all units must have access to scanning,
as it can be a necessary part of pre-abortion assessment, particularly
where gestation is in doubt or where ectopic pregnancy is suspected.
It is the most accurate means of confirming intrauterine pregnancy
and gestational age. Ideally, two sonograms are required in each
case of medical abortion, one for pregnancy dating and confirmation
of intra-uterine pregnancy, second for confirmation of complete
abortion at follow-up. But routine use of USG is a barrier to wider
acceptance of medical abortion. Only a few centres have access to
office-based sonography. Extensive experience has shown use of ultrasound
in only 30% of the time.
Indications for USG are :
For dating of pregnancy in
• Women not sure of their LMP
• When there is discrepancy between
LMP and uterine size
• Abnormal last menstruation
• Women with irregular cycles
• History of intake of oral pills
For confirming intrauterine pregnancy in case
of
• History of bleeding per vaginum
• Risk of ectopic pregnancy
• Doubtful early pregnancy failure
For confirmation of complete abortion at follow-up,
when there is
• No History of passing products
of conception
• No History of cramping
• History of prolonged bleeding per
vaginum
• Big size of uterus on follow-up
For confirming suspected any other gynaecological
pathology
(v) Cervical Cytology or Pap Smear(Screening for
Cervical Cancer)- Assessment prior to induced abortion may
be viewed as an opportunity to ascertain each woman’s cervical
cytology history. Women who have not been screened before, and in
women with clinical symptoms or suspicious
cervix, Pap smear examination may be offered iffacilities are available.
If a cervical smear is taken opportunistically within the abortion
service, then it must be ensured that the smear result should be
communicated to the woman.
D. Pre-Abortion
Counselling
Counseling of abortion patients presents special challenges because
of the physical and emotional stress associated with unwanted pregnancy
and abortion. Information must be complete, accurate and easy to
understand and be given in a way that respects the woman’s
privacy and confidentiality. It should be voluntary and provided
by a trained person.
Information and counseling should be provided
regarding :
• Options available for pregnancy
termination
• What will be done during and after
the procedure, what she is likely to experience and how long the
procedure will take
• Procedure, its associated risks
and complications
• Sequence of events
• The need for surgical termination
in cases of failure (i.e. continuation of pregnancy) or incomplete
abortion or missed abortion
• Discuss the temporary spacing or
permanent method of contraception for future fertility regulation
• Advantages (no risk of surgery
or anaesthesia, future fertility not affected) and disadvantages
(prolonged bleeding, chances of failure, teratogenesis and minimum
three clinic visits) of medical abortion should be explained
• When she will be able to resume
her daily activities
• Follow-up care
E.
Informed consent
This should be taken as per the existing MTP Act. F.
Unresolved Issues
• Necessity of Ultrasound in all patients
undergoing medical abortion.
| RECOMMENDATIONS |
1. Medical termination
of pregnancy is legally permissible up to 20 weeks of gestation
according to the MTP Act of India, 1971.
a) First trimester termination of pregnancy with medical
methods of abortion is recommended by GOI up to 49 days
of gestation; the expert group recommended this is to be
extended up 56 days amenorrhoea (8 weeks pregnancy);
b) Second trimester termination (13-20 weeks) has not obtained
approval of Government of India by medical methods of abortion
till date, and is to be done in hospitals only under research-setting.
2. Relevant gynaecological history (1st day of the last menstrual
period LMP) should be taken to rule out ectopic pregnancy. IUD
in situ should be ruled out.
3. Medical contraindications including drug allergy to medical
abortion should be excluded before providing medical abortion.
4. Caution should be exercised in patients with fibroid uterus
or in those with previous surgery on uterus or cervix.
5. Essential investigations to be done are haemoglobin, urine
routine microscopy, blood grouping and pregnancy test.
6. Ultrasound is not mandatory but should be performed in doubtful
cases for confirmation of
intra-uterine pregnancy, dating of pregnancy and to evaluate
completeness of abortion at
follow-up visit.
7. Cervical screening (Pap smear) can be offered to women at
the time of pre-abortion check-up.
8. Pre-abortion counseling should include the other options
available for pregnancy termination, associated risks and complications,
drug failure, risk of teratogenesis, contraception advice and
written informed consent. |
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