Oral Misoprostol versus Vaginal Dinoprostone for Induction of Labour: a Randomized Controlled Clinical Trial

Abstract

I nduction of labour is a very common obstetric procedure, performed in about 15-30% of pregnancies, either for maternal or fetal indications. Induction of labour is a process that changes a pregnancy from a certain level or risk to a higher one, as it may lead to certain complications to both the mother and the fetus such as fetal distress, uterine rupture, operative vaginal delivery and caesarian sections. Several inducting agents have been used along the years and the two most commonly used now are Misoprostol (PGE1) and Dinoprostone (PGE2). When comparing the two drugs we take into account two main ideas; efficiency and safety, this doesn’t mean that we should miss “cost-effectiveness”. Misoprostol is a synthetic prostaglandin E1 analog and has been reported to be a considerably safe and effective cervical ripening agent. It is inexpensive, easy to administer, stable at room temperature, does not require refrigeration. In spite of different doses and routes of administration (sublingual, oral, vaginal), ideal dosage and mode of administration still remain to be controversial. Potential complications such as uterine rupture, tachysystole and uterine hyperstimulation should be emphasized with respect to adverse maternal and neonatal outcome. A considerable amount of work has concentrated on optimum dosing regimen that minimizes the risk while maintaining efficacy since both efficacy and side effects are suggested to be dose dependent. At present, the only agent specifically approved by US Food and Drug Administration (FDA) for labor induction is dinoprostone. Dinoprostone; a PGE2 analog has been shown to be an effective agent of cervical ripening and labor induction, available as gel, tablet, insert or suppository. However, it is expensive, requires refrigeration and mostly needs oxytocin augmentation. In this study we were concerned with determining whether oral misoprostol was a safe and effective alternate to dinoprostone, since misoprostol was cheaper and heat stable it appears to be without a doubt a cheaper effective and safe alternate, especially in developing countries. This is a randomized clinical trial conducted at Ain Shams Maternity Hospital in the period between August 2014 and February 2016. A total of 342 eligible primiparous women were recruited and randomized into two groups, OMS and VDP.