Background
Medical abortion methods promise to change
women’s reproductive lives as the oral contraceptives did
40 years ago. It also promises to increase dramatically the numbers
and nature of abortionproviders from a small cadre of doctors to
include other healthcare-providers and change the venue of abortion
from the clinic to home.
QUESTIONS TO BE ANSWERED
A. Who are the candidates for medical abortion?
B. What should be the level of provider?
C. What should be the level of healthcare facility?
D. Should drugs be available over the counter?
E. Where should the drug be administered?
VIEWS OF THE GROUP
The group discussed on who should be the candidates and providers
for medical abortion; and where abortion can be done including modalities
for procurement of drugs.
A. Candidates for Medical Abortion
Option of medical termination of pregnancy up to 49 days from the
LMP (approved by Government of India) by the medical method should
be given to all women coming to a health facility. Effectiveness and
safety of mifepristone-misoprostol combination for termination of
pregnancy up to 56 and 63 days has also attained enough evidence that
it can be recommended in future.
Inclusion criteria :
• Patient should accept the projected time-frame for medical
abortion.
• Should be willing to return for minimum 3recommended clinic
visits.
• Easy physical or telephonic access to back-up or emergency
facilities
• Consent for surgical procedure implied, counseled for and
accepted in case of failure or excessive bleeding.
Exclusion Criteria
Medical Contraindications
a. Confirmed or suspected ectopic pregnancy
b. Undiagnosed adnexal disease
c. Anaemia (Hb < 8 gm/dl)
d. Coagulopathies or on anticoagulants
e. Current use of long-term systemic steroids
f. Chronic adrenal failure, g. Uncontrolled hypertension
h. Cardiovascular disease – angina, valvular disease, cardiac
failure i. Jaundice
j. Severe renal disease
k. Glaucoma l. Uncontrolled seizure disorder
m. Allergy or intolerance to mifepristone or misoprostol
n. Misplaced IUD with pregnancy which cannot be removed before medical
abortion
Social and psychological Contraindications
a. Women unable to take responsibility
b. Anxious women wanting quick abortion c. Women unable to come for
follow-up
d. Language or comprehension barrier, thus unable to understand instructions
e. Lack of access to emergency services Relative
Contraindications
a. Pregnancy with large fibroids distorting the endometrial cavity
can cause heavy bleeding and interfere with uterine contractility
b. In women who conceive with IUD, it should be removed before medical
abortion
c. Surgical abortion is preferred if patient desires concurrent tubal
ligation
d. Pregnancy with valvular heart disease Caution
is required in women having
a. Pregnancy with uterine scar (single/ multiple) - of caesarean,
hysterotomy or myomectomy
b. Bronchial asthma is not a contraindication as misoprostol is a
weak bronchodilator.
c. Concurrent use of anti-tubercular drugs decreases the efficacy
of medical abortion pills. Either the dose should be increased or
vaginal administration done. Not much research has been done in this
field
B.
Level of Provider
The provider of medical abortion services should be a registered medical
practitioner as prescribed by MTP Act Definition 2(d), Section (2)
and MTP Rule 3.
Medical practitioner with postgraduate training or qualification in
Obstetrics and Gynecology is automatically recognised. There is scope
to train other medical practitioners in safe abortion techniques at
recognised training centres.
In future
• Bifurcate recognition requirements for providers of first
and second trimester terminations in MTP Rules.
• MBBS doctors trained in medical abortion can be certified
in a recognised institute as a third tier of providers.
• There can be separate medical and surgical abortion clinics
or separate first trimester daycare and second trimester indoor
hospital facilities.
Physicians who prescribe drugs for medical abortion must be able
to accurately date a pregnancy, determine that the pregnancy is
not an ectopic gestation, provide for the patient to receive a surgical
abortion, if necessary, and assure that the patients has access
to a medical facility equipped to provide blood- transfusion and
resuscitation services 24 hours.
C. Level of Health Care Facility
Healthcare facilities approved by GOI to perform medical termination
of pregnancy are
• PHCs (Primary Health Centres) with 24-hour facilities
• CHCs (Community Health Centres), government and teaching
hospitals where MTP facilities are already available
• Private clinics and hospitals registered under the MTP Act.
Private practitioners qualified as per the MTP Act with identified
back-up facility could be allowed administration of drug at their
clinic. According to the current scenario, Section 4 (b) of the
MTP Act defines the settings as
• A hospital established or maintained by the government
• A place approved for the purpose of the Act Rule 4 of the
MTP Rules further elaborates Clause 2, i.e.
• The Government should be satisfied with safety and hygiene
• The following facilities should be provided
a) OT table and instruments for abdominal and gynaecological surgery
b) Anaesthetist, resuscitation and sterlisation equipment
c) Drugs and parenteral fluids for emergency need
Registration and Approval :
Suggested explanation in MTP Rules. Medical methods for termination
of pregnancy not exceeding 7 weeks may be prescribed by a registered
medical practitioner as described under Section 2(d), Rule 3, having
access to a place approved by the Government under Section 4(b),
Rule 4(1), for surgical and emergency back-up when such is indicated.
Emergency Care facilities : Establishment
of linkages
• At initial prescription and counseling, provide information
about emergency access facilities and telephone numbers.
• To identify back-up facilities, create linkages with address
available for referral (MTP recognised centre).
• Identify, round the clock, private or public hospital facilities
with availability of blood-transfusion and for transfer of complicated
cases.
In future
• To make registration of MTP centres easy by rationalising
and simplifying requirements for 1st trimester termination as opposed
to second trimester termination in MTP Rules.
• Recognition and approval of clinic-based use by 3rd tier of
MBBS providers.
• Paramedics (ANMs and nurses) can administer the drugs and
monitor women as long as the doctor has evaluated the women for
suitability and prescribed the drugs. The follow-up is also to be
done by the doctor.
• Family planning clinics can play an importatnt role in providing
medical abortion services in India.
D. Supply of Medications -
Over the Counter Availability
• Currently, the drugs are available only to the registered
doctors.
• Drugs should be dispensed by an RMP approved to perform
MTP.
• From a government pharmacy
• From retail outlets on the prescription of gynaecologists
and MTP approved RMPs.
In future
• Prescription for medications should bear qualification and
State Medical Council Registration number.
• Prescription of RMPs with MBBS qualification should include
inscription "Certified to perform MTPs".
• In the current Indian scenario, over the counter provision
of medical abortion drugs is not permissible
E. Administration of drug:
Home versus Healthcare facility
The recommended protocol for three standard visits is as follows:
First visit – Counseling, mifepristone administration
and emergency access information
Second visit – Misoprostol administration (recommended
but optional)
Third visit – Follow-up at around 14 days from the
first visit
While appreciating the advantages of a three visit clinic-based
administration, there should be the option of home administration
of one or both drugs as per clinical discretion, with a follow-up
clinic visit as recommended at 2 weeks.
Providing the option of home administration of drug can offer a
simpler, more convenient and less expensive medical abortion regimen
that is safe, effective and acceptable in less-developed countries.
Feasibility of home administration of misoprostol has increased
the satisfaction rates among women taking the drug at home.
In a select group of women with early pregnancy, the visit to ingest
mifepristone and misoprostol is not necessary and even follow-up
visit can be replaced by telephone follow-up.
Second Trimester Termination
• Provider and site should be as per existing MTP Rules and
Regulations
• Specific tier for second trimester providers with appropriate
credentials and training should be defined
• Adequate hospital-based facilities with emergency back-up
should be maintained
• The safety and privacy of medical methods over surgical
techniques should be acknowledged
• Experience of use of ethacridine lactate, both alone and
in combination, is well-documented
• The universal evidence of successful use of misoprostol,
alone, or in combination, is well- accepted; approval could be considered
by Drug Controller and guidelines would be formulated
F. Unresolved Issues
• Till MTP rules are modified, one has to follow the existing
rules of MTP Act.
| RECOMMENDATIONS |
1. Termination
of pregnancy by medical methods of abortion is approved by GOI
till 49 days of gestation. In future, pregnancy termination
up to 56 and 63 days of amenorrhoea also can be offered to women,
as there is enough evidence of its safety and success.
The same also holds true also for second trimester pregnancy
termination (13-20weeks).
2. Pregnancy with fibroid uterus is a not a contraindication
for medical abortion except when it is large and distorts
the endometrial cavity (relative contraindication).
Patients having bronchial asthma are also not a contraindication
to the use of misoprostol (weak bronchodilator).
Pregnancy with previous scarring on uterus (caesarean, myomectomy
and hysterotomy) does not contraindicate the use of methods
of medical abortion.
3. Removal of IUCD in patients who conceive with IUD in situ
make them eligible for medical abortion.
4. Women wanting concurrent tubal ligation should be counseled
for surgical abortion.
5. Providers of medical abortion services should be RMPs as
approved by Government of India according to the MTP Act Definition
2(d), Section 2, and Rule 3. Providers of first and second trimester
pregnancy termination can be bifurcated in future. MBBS doctors
can be trained and certified to provide medical services as
a third tier of providers.
6. Level of healthcare facility required to perform medical
abortion should meet the requirements of Section 4(b) and
Rule (1) of the MTP Act i.e. a hospital established or maintained
by the government or a place approved for the purpose of the
act.
7. To make registration of MTP centres easy that are recognised
for first trimester termination.
8. To acknowledge the safety of medical over surgical methods
for second trimester termination and formulate guidelines
accordingly.
9. Availability of drugs should be only on prescription of
gynaecologists and MTP approved RMPs. Such prescription should
bear the qualification and State Medical Council Registration
Number and the inscription "Certified to perform MTPs"
for MBBS providers.
10. Home administration of one or both drugs can be made an
option only on clinical discretion with mandatory follow-up
visit at 2 weeks. It offers women more choice, control and
privacy in managing their abortions.
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