A randomized controlled trial comparing combined medical and mechanical method for early mid-trimester abortion (13-20 weeks).

Abstract

To examine the combined effect of a medical and mechanical method on induction-to-abortion interval (IAI) in women undergoing early mid-trimester abortion (MTA) (13-20 weeks of pregnancy). A randomized controlled trial was conducted among women undergoing MTA. Primary outcome was IAI. At enrollment, 60 women were randomized (group 1: medical method alone [mifepristone 200 mg, then 48 h later vaginal misoprostol 400 μg every 4h] versus group 2: combined medical and mechanical method [transcervical Foley catheter inflated with 60 ml of normal saline]). Demographic and clinical data were collected at enrollment and abortion. Women in group 2 had statistically significantly shorter IAI (mean ± standard deviation: 347 ± 130 min vs. 640 ± 242 min, for group 2 and group 1, respectively; P< 0.001). All the women in group 2 had complete abortion within 12 h, compared with 19 (63%) in group 1 (P< 0.001). Median number of doses of vaginal misoprostol (400 μg every 4h) required in group 1 was 4 (interquartile range [IQR] 3-5) versus 1 (IQR 1-3) in group 2 (P< 0.001). Statistically significantly fewer women required additional oxytocin (group 1 vs. group 2; 4 vs. zero, respectively, P= 0.038). All women in the study had complete abortion. There was no significant difference with respect to maternal complications. A combined medical and mechanical method significantly shortens the IAI (P< 0.001) in women undergoing early MTA (13-20 weeks of pregnancy). Clinical Trial Registry of India www.ctri.nic.in CTRI/2020/12/030077 (date; 28-12-2020).