The guidelines that follow have been prepared by WHO-CCR in Human Reproduction, All India Institute of Medical Sciences, in collaboration with Ministry of Helath & Family Welfare,GOI and Indian Council of Medical Research to assist all those who provide medical abortion services under the MTP Act and ensure safe usage for early medical abortion in India. Currently the medical abortion in India is approved upto 7 weeks of amenorrhoea.

I. Indications for early medical abortion

Option should be given to all women coming to a health facility seeking termination of pregnancy up to 7 weeks period of gestation (49 days from the first day of the last menstrual period in women with regular cycle of 28 days) provided the following aspects have been assessed and found appropriate:

- acceptability of minimum three follow- up visits
- can understand the instructions

Only registered medical practitioners as prescribed by the MTP Act are authorized to prescribe mifepristone with misoprostol for medical abortion [Definition 2(d) of section 2 and MTP rule 3].

Mifepristone with misoprostol for termination of early pregnancy not exceeding seven weeks, may be prescribed by a registered medical practitioner as prescribed under section 2 (d) and rule 3, having access to a place approved by the Government under section 4 (b) and rule
4 (1), for surgical and emergency back-up when such a back-up is indicated.

This may include primary healthcare-clinic or hospital-based set-up. Initial workup, counseling, prescription and administration could be in a clinic or in the consulting room. Home administration of misoprostol may be advised at discretion in certain cases with an access to 24-hours emergency services.

• Vacuum Aspiration (Suction evacuation) is the most commonly-used method for termination of early pregnancies. However, being a surgical technique, it is associated with risks of infection, perforation of uterus, incomplete abortion and post-procedure uterine synechiae formation (Asherman’s Syndrome).
• The success of abortion with drugs depends on multiple factors including the regimen used, dosage schedule, route of administration and gestational age. However, after counseling, the woman should be allowed to make an informed decision.
• Mifepristone with misoprostol is favourable if pregnancy is = 7 weeks.
• Surgical abortion is preferred if patient desires concurrent tubal ligation.
• If a woman fulfills the criteria for selecting either method, final choice to be given to the woman.

II. Contraindications for medical abortion

a. Early medical abortion is contraindicated in women with

• pregnancy with intrauterine device (IUD) in situ: IUD has to be removed before medical abortion.
• pregnancy with fibroid: Women with symptomatic large fibroids encroaching on endometrial cavity can have heavy bleeding and fibroids may interfere with uterine contractility
• pregnancy with uterine scar: Caution should be exercised when medical abortion is offered to patients with previous history of caesarean section, hysterotomy or myomectomy.
• bronchial asthma: other prostaglandins should not be used in women with bronchial asthma except misoprostol which is a weak bronchodilator, and may be used.
• use of anti-tubercular drugs: this may decrease the efficacy of medical abortion pills. Patient should be counseled about the increased risk of failure requiring surgical abortion.

c. Psycho-social situations unsuitable for medical abortion

• women unable to take responsibility
• anxious women wanting quick abortion
• language or comprehension barrier
• not willing for surgical abortion in case of failure

• acceptability of a minimum three follow-up visits
• family support
• easy access to appropriate healthcare facility
• probability of the need for a surgical procedure in case of failure or excessive bleeding
• side-effects of the drugs and
• risk of congenital malformation in case of continuation of pregnancy.

The following information should be given to all those women who are suitable and who wish to have termination of pregnancy with drugs:

• She will require visit to hospital/clinic on three occasions:

First Visit (day 1): to take Tab Mifepristone 200 mg orally, in the presence of a health functionary.

Second Visit (day 3): to take tablet Misoprostol, 400µg.

Third Visit (day 15): to ensure that abortion is complete.

• Following use of this method of abortion, vaginal bleeding usually occurs for 10-14 days; it is more like a heavy, prolonged menses. Sometimes, a small embryo may be visible in the blood clot.

• In case of failure of this method, she will require to undergo surgical abortion by suction evacuation (vacuum aspiration) as it will not be advisable to continue pregnancy.
• In case of heavy bleeding any time, she will have to report to her doctor/clinic immediately to decide whether a suction evacuation is needed to control bleeding.
• Her next menses may be delayed by one to two weeks, but subsequent menses will come on time.
• She has full option of choosing suction evacuation for terminating her pregnancy if she does not want to use medical abortion.
• During treatment and, preferably, till the next menses, she will have to avoid intercourse.
• She will have to sign a consent form after being satisfied with all the information provided, and after getting satisfactory answers to any doubts that she may have in mind.

IV. Pre-abortion work up and investigations

- pallor, blood pressure, cardio-vascular and respiratory system
- bimanual examination to confirm the duration of pregnancy

- Ultrasound dating of pregnancy may be done in women who are:
- unsure of dates
- have conceived during lactational amenorrhoea - have irregular cycles
- have a discrepancy between history and clinical findings.

Standard dose for mifepristone is 200 mg given orally followed by 400µg misoprostol oral/vaginal according to the discretion of the clinician. The process of termination of pregnancy with mifepristone differs from surgical, in that, the exact time of pregnancy expulsion is not clear and is often not obvious to the women.

• history of any bleeding or side-effects should be noted.
• oral/vaginal misoprostol 400 µg is given.
• for vaginal use, misoprostol tablet should be moistened with a few drops of water and the women must lie in bed for half an hour.
• she should be observed for 4 hours in the clinic/hospital.
• pulse and blood pressure are to be monitored and any side-effects noted.
• the time of start of bleeding and expulsion of products is noted.
• a pelvic examination is done before the woman leaves the clinic and if cervical os is open and products are partially expelled, these are digitally removed.
• drugs for pain relief are prescribed if required.
• patient should be advised to abstain from intercourse, or to use condoms, till the next visit.
• she is instructed to take adequate rest and avoid going out of station.
• she should report in case of excessive pain or bleeding.

• a clinical history and pelvic examination should be done to ensure that there are no complications.
• ultrasonography is required if history and examination do not confirm expulsion of products of conception.
• if she is still having irregular bleeding, curettage may be required.
• the woman should be informed that her next periods may be delayed but should come for a check-up if she does not get period in 6 weeks.
• contraceptive advice is given and appropriate contraception provided.

• Routine use of prophylactic antibiotics is not indicated except:

- women having home administration of tablets
- nulliparous
- women with presence of vaginal infections.

• Pain is an accompaniment of the process of abortion. Women counseled properly may tolerate pain better with less use of analgesics.
• Paracetamol or a narcotic analgesic may be used for pain relief.
• The use of non-steroidal anti-inflammatory drugs (NSAIDs) is not favoured because of their action as prostaglandin synthetase inhibitor.

c. Role of antiemetics and antidiarrhoeals

• Gastrointestinal side-effects such as nausea (12- 47%) vomiting (9-45%) and diarrhea (7-67%) occur with varying frequency, but are generally mild.
• Pre-abortion counseling helps and routine administration of antiemetics is not necessary.
• If the patient vomits within half an hour of taking the tablet, antiemetics should be given followed by a repeat dose half an hour later.
• Mostly the diarrhea is self-limiting and antidiarrhoeals are not required.

The common side-effects of RU-486 with misoprostol for termination of early pregnancy are related to the abortion process, pregnancy itself and the effect of drugs used. The side effects are dose-dependent. Common effects include:

• pain
• bleeding
• nausea
• vomiting
• diarrhea
• headache
• feeling of warmth
• chills
• dizziness and fatigue

• Proper case selection, adequate counseling and appropriate referral are the key to the success of medical abortion.

• At initial prescription and counseling, make available the information about emergency access facilities and telephone numbers.

• All providers of medical abortion need to clearly instruct women to contact predetermined referral centre with 24-hour facility in case of emergency. The name of the doctor and telephone number should be clearly written. The referral centre must be registered as per MTP Act, with a qualified provider, and should have facilities of IV fluids, blood transfusion and surgical evacuation.

Failure with medical abortion is a term used when a surgical curettage is performed for any reason including clinician’s decision, patient’s choice or a true drug failure. True drug failure is defined as the presence of gestational cardiac activity 2 weeks following mifepristone and misoprostol administration. It occurs in < 1 % of women and pregnancy should be termination by surgical evacuation.

Ectopic pregnancy should be excluded if the woman does not expel products following therapy and/or is having pain.

Pre-abortion counseling should emphasize that bleeding is likely to be heavier than menses, comparable to that of a miscarriage. She should be told that soaking 2 pads per hour for 2 hours in a row is all right at the time of peak cramping which is often the case when the pregnancy expulsion occurs. However, if this persists and/or the woman is dizzy, she should consult the doctor. Severe bleeding necessitating a surgical curettage, is reported in less than 1% patients and depends on:

– the clinician’s assessment of blood loss (severe pallor, signs of hypovolemia)
– presence of circumstances that make it difficult for patient to obtain emergency help later
– patient’s preference.

Crampy abdominal pain is experienced by most women for a short time, coinciding with expulsion of products of gestation. Pain relief is an important part of the therapy. The perception of pain is modified by fear, anxiety and emotions, but, often, women are relieved by paracetamol. A mild opioid such as codeine/ oxycodeine is often added to paracetamol in current US protocols.

Pain usually subsides once the products are expelled. Persistent pain, with failure to respond to these drugs for several hours, warrants evaluation for other causes, such as ectopic pregnancy, infection or incomplete abortion.

Fever or a feeling of warmth is thought to be a component of the prostaglandin analog used. It is usually short-lived and resolves spontaneously. Acetaminophen (Paracetamol) given for pain relief also takes care of fever, but if temperature exceeds 100.4°F (38°C) or persists for several hours despite antipyretics, infection should be ruled out.

Women having a persistent gestational sac without cardiac activity 2 weeks after mifepristone and misoprostol administration are diagnosed to have incomplete abortion. Such women usually do not have pregnancy-related symptoms and, often, spontaneously expel the products approximately 36 days after mifepristone administration. The clinician must understand that, during medical abortion, once the gestational sac is expelled, the uterus will normally contain blood, blood clots and decidua, which appear as hyperechoic tissue on ultrasonography. In the absence of excessive bleeding, these patients should be followed conservatively.

This should be explained to the woman if she does not abort following administration of RU-486 with misoprostol abortion pills. It is, therefore, advisable to terminate pregnancy surgically. A written statement signed by the woman must be kept on record if surgical termination is refused.

Next menstruation can occur from 3-6 weeks after the abortion and is usually normal. Contraception should be initiated within 15 days of abortion as pregnancy can occur, causing persistent amenorrhoea.

• Women should be encouraged to come for follow-up when they have their menstrual period following abortion.
• Contraception should be offered to all women seeking medical abortion, as future fertility is not affected therewith.
• Oral combined pills or DMPA can be started on Day 15 if the abortion process appears to be complete.
• Copper T must be inserted after one normal period.
• Condoms should be used if the woman has intercourse prior to Day 15 follow-up visit, though abstinence is preferred.
• Women desiring concurrent tubal ligation should be counseled for surgical abortion, initially only, when two can be combined. Alternatively, tubectomy can be done after the next cycle if the woman so desires.
• Women should also be counseled about prevention of sexually-transmitted infections and HIV/AIDS.

IX. Record-keeping

• All medical practitioners or the Head of the hospital, where termination of pregnancy is performed should maintain admission register for recording particulars of the women who receive medical abortion drugs.
• This register should include serial number of Medical Abortion (M.A. No.), date of registration, name of patient and her husband/father/ guardian, age, religion, address, marital status, education, duration of pregnancy, reason for termination, obstetric history, significant past medical/surgical history and findings of general/systemic and
pelvic examination and relevant investigations done.
• The prescribed drug protocol should be written clearly, indicating date and time, dose and route of administration.
• The follow-up visits should be recorded with comments.
• This admission register will be a secret document and the particulars of the pregnant woman shall not be disclosed to any person except under proper authority (as defined by MTP Regulations, 1975 section of MTP Act 1971).
• Entries made in the case-sheet, OT register, follow-up card or any other document or register (except the admission register) should not disclose the identity of the pregnant woman in any way.
• Destination of admission register and other papers: as per MTP Regulations, 1975. a.

A record of complications pertaining especially to heavy bleeding necessitating the use of IV fluids, blood transfusion or curettage, sepsis, incomplete abortion, continuation of pregnancy, adverse drug reactions, etc. should
be maintained.