A Randomised Control Trial to Know The Safety and Efficacy of Oral Mifepristone In Preinduction of Labour in Post Dated Pregnancy.

Abstract

Background and Objectives: The aim of present study is to evaluate the safety and efficacy of oral mifepristone and dinoprostone gel for pre induction cervical ripening versus dinoprostone alone in postdated pregnancy. Methods : •The following study included 130 pregnant women as samples with diagnosis of post dated pregnancy and due for induction of labor. Detailed history of all the patients taken according to the proforma and complete examination and all necessary investigations done. Informed written consent has taken from the participants. •The sample size for the study is 130. Women will be randomized into two groups according to computer generated randomized table. The number of participants in study group will be 65 and control group will be 65. •Women randomized to study group will receive one tablet Mifepristone 200 mg per oral at the moment of enrollment, later on patient will be reviewed for Bishops score after 24 hours. The participants in control group will not receive anything. •After 24 hours, both groups will receive dinoprostone gel 0.5 mg every 6th hourly until Bishops score is > 8 or maximum for 3 doses. •Before each dose of dinoprostone gel fetal wellbeing will be evaluated by clinical examination and Cardiotocography . •If with 3 doses of dinoprostone gel the Bishops score not improved then the induction will be categorized as failed induction. DocuSign Envelope ID: 9C9B001258D01AF0--9363B48D--44822CB1--B96B5635--90CA36CEFD561BC84A59B22B x •When the women entered in active labor, augmentation of labor will be done by using Oxytocin drip, but not earlier than 6 hours from last dose of PGE2 gel application. RESULTS : The age range varied from < 20 years to > 30 years. Most common age group in mifepristone along with cerviprime group is < 20 years constituted 24 (36 % ) patients and in cerviprime group is 20-24 years ,constituted 37 with ( 56 % ) . The mean age of mifepristone and cerviprime group and dinoprostone gel alone group is 22.82 and 23.66 years respectively. In the present study we observed the number of multiparous women were higher than primiparous women. Multiparous and primiparous women are 52.3% and 47.7% respectively in mifepristone and cerviprime group; and in dinoprostone gel alone group respectively. The commonest side effects observed in control group as constituted 5 % patients each. While analyzing for side effects we found a highly significant difference in two groups. The time taken from induction to active phase is higher in study group with mean 17.21 ,than in control group with mean 10.53. Time taken from induction to delivery was higher in study group with mean 22.10, and in control group with mean 15.063. Total number of vaginal deliveries in study group was lesser than in control group with mean values 62.5 % and 67.7 % respectively. Conclusion : This study reveals that oral mifepristone along with cerviprime is very safe and an effective drug for pre induction cervical ripening. It has an advantage of, better patient compliance and acceptance, reduced oxytocin requirement, ease of administration .The drug has less side effects on uterine contraction and no major maternal complications. This drug has safe neonatal outcome. This drug is more effective in multigravida when compared to primigravida. Hence mifepristone offers advantages over PGE2 gel which is currently used for preinduction cervical ripening.