Category B: Poster Presentations: Early Pregnancy and Acute Gynaecology

We aim to legalise medical termination of pregnancy (TOP) between 10 and 20 weeks of pregnancy in India by demonstrating its safety, efficacy and acceptability as part of a prospective randomised multicentric trial. Methods After ethical approval, screening women for eligibility for the trial was followed by informed consent and randomisation into one of two groups (Group A 24 hours and Group B 48 hours). After assessing for vitals, they were given tablet Mifepristone. This was followed 24 or 48 hours later by tablet Misoprostol as per group allocation. For this, the patient was admitted to hospital and given vaginal and sublingual misoprostol (as per protocol) till complete expulsion of fetus and placenta. Patients were given a diary card at discharge (to note for bleeding, pain, nausea, vomiting, diarrhoea, dizziness, rash and chills) and followed-up at 2 weeks or earlier if there were any complications. Data were maintained regarding age, parity, previous caesarean delivery, reason for TOP, days from last menstrual period, induction–abortion interval, gross evaluation of the fetus, need for curettage, side-effects of drugs and satisfaction with procedure. Results In all 105 women were screened for eligibility, of whom 21 were excluded as they did not meet the inclusion criteria. Four dropped out for personal reasons and 80 women completed the study over a period of 18 months. After randomisation using blinded envelopes, 41 patients were allocated to Group A and 39 to Group B. Mean duration of pregnancy was 106.2 (SD + 17.0) days. Majority of the women were para 3 or less, 27% had a previous caesarean and 15% had an anomalous baby. The most common reason for seeking TOP was contraceptive failure (80%). Data for the two groups were compared regarding induction– abortion interval (IAI) and side-effects. IAI was significantly shorter in Group B (P = 0.009). Only one woman failed to abort the fetus with this regimen and needed a surgical evacuation. Three women required readmission for curettage due to delayed bleeding. At the 2-week follow-up visit, diary card review showed that 83% of patients were asymptomatic. Ten percent of women had an extra visit before or after the follow-up visit for symptoms like breast engorgement and urinary infection. Patient satisfaction with either regimen was 97.5%. There were no cases of pelvic sepsis or uterine perforation. Conclusions Medical TOP using mifepristone and misoprostol may safely be extended beyond the current legal limit of 9 weeks of pregnancy as it is safe, efficacious and well accepted by patients. Category B: Poster Presentations: Early Pregnancy and Acute Gynaecology