A randomized controlled unmasked trial comparing safety and efficacy of oral misoprostol with intravenous oxytocin for induction in prelabour rupture of membranes at term

This is a prospective  randomized controlled unmasked trial which will be done in pregnant women at term  with pre-labour rupture of membranes. Active or planned management in pre-labour rupture of membranes redues maternal infectious morbidity and   neonatal care unit admission  when compared to  expectant management [1]. There are different methods of induction of labour for pre-labour rupture of membranes. In this study we are comparing oral misoprostol to intravenous oxytocin for induction of labour.  Research done in this institution [2] on term inductions without rupture of membranes has shown that women in the group that received oral misoprostol were more likely to develop uterine contractions without oxytocin than women given vaginal  misoprostol. Thus due to ease of administration especially in women with rupture of membranes ,we deciced to use oral misopostol. Women in the arm randomized to oxytocin will be induced with usual oxytocin protocol followed in labour room for induction of labour. Women randomized to oral misoprostol will be given oral misoprostol 50mcg at four hourly inteval maximum of three doses in primi gravida and two doses in multi gravida.These women then be induced with oxytocin after twelve hours of first dose of oral misoprostol if they do not have uterine contractions.After informed consent, women will be recruited from labour room and randomized to either of the groups. Data regarding duration of labour, fever ,CTG abnormalities, neonatal morbidity etc, will be collected. The data collected will be  analysed to compare safety  and efficacy in both groups.  BIBLIOGRAPHY:

1.Dare MR, Middleton P, Crowther CA, Flendy FJ, Varatharaju B. Planned early birth vresus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more).Cochrane Database Syst rev  2006 jan 25;(1):CD005302.

2. A radomized double mask placebo controlled  trial comparing oral misoprostol with vaginal misoprostol for induction of labour. Dr.HIlda Yenuberi, Dr.Anuja Abraham, Dr.Ajit Sabastian, Dr.SAnthosh Joseph Benjamin,Dr.Visalakshi Jayasheelan, Dr.Jiji Elizebeth Mathew Awaiting Publication.