Pikee Saxena1, Sudha Salhan, Nivedita Sarda. 1. Department of Reproductive Biomedicine, National Institute of Health and Family Welfare, New Mehrauli Road, Munirka, New Delhi 110067, India. pikeesaxena@hotmail.com
Abstract
BACKGROUND: Sublingual and vaginal routes of misoprostol have been found to be effective for pharmacological ripening prior to surgical termination of first trimester abortions. We conducted this study to compare the effectiveness and acceptability of sublingual versus vaginal route of misoprostol for cervical priming prior to vacuum aspiration (VA). METHODS: In this prospective clinical trial, a total of 100 women with period of gestation between 6 and 12 weeks scheduled for day surgery abortion were sequentially allocated into two groups of 50 each. All participating women received 400 microg of misoprostol 3 h prior to VA either by sublingual (self-administered at home) or by vaginal route (inserted by the doctor in hospital) after wetting the tablet with water. RESULTS: Demographic characteristics of both the groups were comparable. For all periods of gestation, sublingual misoprostol significantly improved cervical dilatation (p<0.001) and reduced the time duration of surgery (p<0.001) compared to vaginal group without increasing the side effects. Mean pain score of the sublingual group was 2.7+/-1.1 as compared to 3.2+/-1.6 of the vaginal group (p=0.57). Misoprostol tablet was found intact in the vagina of three patients and was only partially absorbed amongst five patients at the time of VA. CONCLUSION: Sublingual route is an effective and convenient alternative to vaginal administration of misoprostol for cervical dilatation. It can be conveniently self-administered at home thereby decreasing hospital stay and cost. It also has a good patient acceptability rate.
RCT Entities:
BACKGROUND: Sublingual and vaginal routes of misoprostol have been found to be effective for pharmacological ripening prior to surgical termination of first trimester abortions. We conducted this study to compare the effectiveness and acceptability of sublingual versus vaginal route of misoprostol for cervical priming prior to vacuum aspiration (VA). METHODS: In this prospective clinical trial, a total of 100 women with period of gestation between 6 and 12 weeks scheduled for day surgery abortion were sequentially allocated into two groups of 50 each. All participating women received 400 microg of misoprostol 3 h prior to VA either by sublingual (self-administered at home) or by vaginal route (inserted by the doctor in hospital) after wetting the tablet with water. RESULTS: Demographic characteristics of both the groups were comparable. For all periods of gestation, sublingual misoprostol significantly improved cervical dilatation (p<0.001) and reduced the time duration of surgery (p<0.001) compared to vaginal group without increasing the side effects. Mean pain score of the sublingual group was 2.7+/-1.1 as compared to 3.2+/-1.6 of the vaginal group (p=0.57). Misoprostol tablet was found intact in the vagina of three patients and was only partially absorbed amongst five patients at the time of VA. CONCLUSION: Sublingual route is an effective and convenient alternative to vaginal administration of misoprostol for cervical dilatation. It can be conveniently self-administered at home thereby decreasing hospital stay and cost. It also has a good patient acceptability rate.
Authors: Shagufta Parveen; Zaffar Abbas Khateeb; S M Mufti; M A Shah; Vishal R Tandon; S Hakak; Z Singh; Shagufta Yasmeen; Shakeel A Mir; Rehana Tabasum; Nasreen Jan Journal: Indian J Pharmacol Date: 2011-04 Impact factor: 1.200