Medical Termination Of Pregnancy With Mifepristone – Misoprostol In Rural India.
Correspondence Address :
Dr Rashmi Sharma MD, DMCH, Clinical Pharmacologist, Govt Hospital Vijay- Pur, J and K Health Services- Jammu, 216-A, Last-Morh, Gandhi-Nagar, Jammu. E.mail: firstname.lastname@example.org
Mifepristone was approved on 28th September 2000 by the FDA for the termination of early pregnancy (49 days or less from the beginning of the last menstrual period)(1). Mifepristone prevents receptor binding of endogenous or exogenous progesterone, resulting in abortion. Mifepristone softens the cervix and sensitizes the myometrium to the contraction-inducing activity of prostaglandins. It also has antiglucocorticoid and weak antiandrogenic activity. The FDA-approved regimen for medica(1). abortion consists of taking 600 milligrams (three 200 milligrams tablets) of mifepristone orally on Day 1 in the provider's office, and 400 micrograms (two 200 micrograms tablets) of misoprostol orally on Day 3, also in the provider's office(2). However, rigorous randomized controlled trials by the World Health Organization have demonstrated similar efficacy with lower doses (200 milligrams) of mifepristone(3). Mifepristone was licensed for use in India in 2002(4). Misoprostol has been available as a medication for gastric ulcer treatment. However, both these drugs can be sold only on prescription (as Schedule H drugs, Drug and Cosmetics Rules, 1945)(4). In addition, the Drug Controller of India registration for mifepristone requires product packaging to mention that it to be used under the supervision of a gynaecologist(4). However, there are reports of the increased trend of medical termination of pregnancy (MTP) among Indian women(5). We conducted a pilot study to analyse the pattern of use of Mifepristone â€“Misoprostol for MTP in rural Indian women.
In the present study, all the women with the history of intake of Mifepristone â€“ misoprostol pills (MAP) within the last one-month attending the Gynaec Out Patient Department of a Government Rural Hospital (GRH) on two fixed days of the week, were included after taking their well informed consent. GRH is located at about 30 kilometers away from the tertiary care hospital, and it caters to the rural population of more than one lac. The study was conducted over a period of six months with effect from 1st February 2007 to 30th September 2007, and a total of 160 women were included in the study. The women visited GRH either for some complication related to MAP use, or to confirm success of medical termination of pregnancy. Ninety (56.25%), 20 (12.50%) and 50 (31.25%) women reported between 10-20 days, 21-30 days, and 2-9 days after administration of mifepristone. All the women were interviewed regarding their demographic characteristics (gravida, qualification, profession, age, duration of pregnancy at which MAP were taken, income of the family), source of information about MAP, MAP taken as self medication or under a doctorâ€™s supervision, concomitant use of other drugs (antibiotics, NSAIDs (anti-inflammatory drugs, iron/calcium, herbal/ayurvedic/homeopathic drugs) and complications or side effects experienced after use of the MAP. All the women were examined for outcome of MAP. Outcome and complications of MAP between self medication and drugs used under the doctorâ€™s supervision group were compared using chi-square test, and P-values less than 0.05 were considered as statistically significant.
Out of 160 women, 90 (56.25%), 30 (18.75%) and 40 (25%) women were multi-gravida, primi-gravida and grand- multi (>5 pregnancies) respectively. A majority of women were undergraduates and non-working (Table/Fig 1). A majority of women were from the middle socioeconomic group, and about 90 (56.25%) women were above 30 years of age [Table/fig 1]. Duration of pregnancy was less than 6 weeks, 6-8 weeks, 9-10 weeks, and 11-12 weeks in 90 (56.25%), 40 (25%), 20 (12.50%) and 10 (6.25%) of women, respectively. However,
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