Background: Induction of labor (IOL) has increasingly become a common procedure, more so in developed countries where the incidence currently averages 20-30%. In developing countries, IOL is variable ranging from 2% to as high as that seen in developed nations. In MTRH, about 5% of all deliveries are term inductions. Nulliparous women often comprise over half of those requiring IOL even in our setting. Additionally, the presence of an unfavorable cervix prior to induction is not uncommon in this group and is often associated with failed inductions, labor dystocia, caesarean sections and longer hospital stays. Hence the need for preinduction cervical ripening using a safe, efficient and cost effective method. This optimal method is not known. Recently, the concurrent use of Foley catheter (FC) with oxytocin for cervical ripening has been studied albeit in primarily Caucasian population. The findings have nonetheless been mixed.

Objective: To determine whether adding low dose oxytocin to preinduction cervical ripening with a FC affects the time to delivery, proportion of deliveries within 24 hours and fetomaternal outcomes in nulliparous women at MTRH.

Methods: This is a randomized double blind placebo controlled trial to be conducted at the Riley Mother and Baby hospital in MTRH. 220 nulliparous women aged at least 18 years with a single, live, vertex pregnancy and scheduled for IOL with an unfavorable cervix at or beyond 34 weeks gestation will be systematically sampled for inclusion in the study. Consenting participants will be allocated to receive FC plus low dose oxytocin or FC plus placebo using block randomisation, with a block size of 20. The primary and secondary endpoints will be at delivery and 24 hours post-delivery respectively. Data will be collected using semi-structured data collection forms and entered into an electronic database using Microsoft Access. Categorical variables will be summarized using frequencies and percentages. Continuous variables will be summarized using mean and the corresponding standard deviation (SD) if the Gaussian assumptions hold or using median and the corresponding inter quartile range (IQR) if the Gaussian assumptions are violated. The time to delivery will be compared between the two arms using independent t-test if the Gaussian assumptions hold or using the two sample Wilcoxon rank-sum test if the Gaussian assumptions are violated. Categorical variables will be compared between the two arms using Pearson’s Chi Square test. Linear regression model will be used to assess the effect of Foley catheter plus oxytocin adjusting for potential confounding variables. We shall report the regression coefficients and the corresponding 95% confidence intervals. Results will be presented using tables and graphs. Data analysis will be done using SAS version 9.4.

Expected findings: The time to delivery has a potentially significant impact on resources and obstetric outcomes. Our study seeks to establish the impact of concurrent FC and oxytocin on the time to delivery and the safety of the same in nulliparous women undergoing cervical ripening in our setting. This will robustly complement previous studies and ultimately inform future protocols with rational, objective and evidence based data.