Oral mifepristone as adjuvant to prostaglandin E2 (PGE2) gel for preinduction cervical ripening and induction of labour in third trimester

摘要

Background: Whenever the intrauterine milieu is not conducive for the foetus and continuation of pregnancy may affect adversely to mother and the fetus, termination of the pregnancy is planned. Objective of this work was to study the safety and efficacy of oral mifepristone as adjuvant to PGE2 gel in pre-induction cervical ripening and induction of labour in third trimester. Methods: 150 patients in third trimester were recruited in this single blind randomized control trial that were planned for delivery with unfavourable cervix. They were randomly allocated into two groups i.e. study group (n = 75) who received Tab. Mifepristone 200 mg orally and control group (n = 75) who received placebo orally. At the end of 48 hours (h), change in the Bishop’s Score was assessed and those with unfavourable cervix or not in labour, were administered PGE2 gel intracervically every 6h, for maximum of 3 doses for pre-induction cervical ripening of cervix. Analysis regarding safety and efficacy of the drug was done with regards to maternal and perinatal outcome. Results: Out of 150 patients, 75 received mifepristone and 75 received placebo. Mean Bishop’s Score showed significant improvement after 48h in study group (R R 5.135, 95% CI 4.78 to 5.48) compared to control group (RR 3.43, 95% CI 3.21 to 3.65). Significant number of women went in spontaneous labour in study group (39 v/s 20) (p - 0.035) in each dose category of PGE2 application. The opportunity to induce labour (with oxytocin) was better in study group in each dose category of intracervical PGE2 gel application. Moreover, lesser number of PGE2 gel was used in study group comparing control group. However, there were no statistical differences in both the groups as far as number of vaginal deliveries and caesearean sections are concerned. Duration of labour in both the groups was same. Neonatal and maternal morbidity was comparable in both the groups. Conclusions: Mifepristone improves Bishops score when given 48 h prior to labour induction along with increased number of spontaneous labour and reduced need for PGE2 gel applications, without increasing maternal or neonatal morbidity.