A randomized controlled trial of oral Misoprostol in the induction of labour at term

Windrim, Rory (1999) A randomized controlled trial of oral Misoprostol in the induction of labour at term. Masters thesis, Memorial University of Newfoundland.

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Abstract

Since the completion of the Canadian Multi-centre Post-term Pregnancy Trial, there has been an increase in the number of inductions of labour at term and beyond term. In many centres, the induction of labour rate exceeds 20% of all deliveries. -- Concomitant with this increase in induction rates has been an increase in the use of vaginal prostaglandin primarily dinoprostone, to aid in pre-induction cervical ripening and induction of labour. Dinoprostone has been administered by the oral route in the past, but because of unacceptable gastrointestinal side effects, it's use has been widely abandoned and replaced by its vaginal administration. -- Because of the high costs and limited administration route of dinoprostone, in recent years attention has turned world-wide to the use of another prostaglandin, misoprostol, in the induction of human labour at term. This medication, initially designed for the treatment of upper gastrointestinal ulcers has been shown to be an effective agent for induction of labour, when administered vaginally. -- The purpose of the trial described in this thesis is to evaluate the efficacy and safety of oral administration of misoprostol in induction of labour, when compared to standard methods of induction. Two groups of patients were formed by random assignation. The first are a control group who received standard care at our unit for induction of labour at term. Standard care for these patients would usually include vaginal prostaglins and/or oxytocin. The second group was the study group. This group received oral misoprostol as the induction of labour agent. The two groups are then compared for both primary and secondary outcome measures. The primary outcome measure is the length of time from commencement of the induction process until delivery. Secondary outcome measures compared between the two groups include multiple parameters of neonatal and maternal morbidity. Finally we were also interested in the acceptability of oral misoprostol for induction of labour as no other prostaglandin induction agent has been shown to have an acceptable side effect profile when administered orally. We therefore also compared labour and delivery maternal satisfaction scores between the two groups. -- This proved to be a negative trial. There were no statistically significant difference in the primary outcome measure (time for induction of labour until delivery) or in any of the secondary outcome measure figures of neonatal or maternal morbidity or maternal satisfaction. -- The thesis will be presented in five chapters. The first chapter (Introduction) will provide an overview of why and how induction of labour has been carried out from historical time until the present for the reader new to this area. In the second chapter (Background) a detailed discussion of the role of prostaglandin in the induction of labour will be presented. This background concerning prostaglandin will be narrowed down to a review of the role of a specific prostaglandin (misoprostol) up to the point where this trial started. To conclude this chapter the rational behind the decision to study oral misoprostol use would be presented. In chapter three (Methodology) the exact research question will be specified. The design we chose to attempt to answer this question will also be described. The very important issues of sample size estimation and justification will then be presented prior to a description of the execution of the design in terms of the description of the institution where the study was performed ethics in content, patient recruitment issues etc. In chapter four (Data Analysis) I will present the results of the trial for both primary and secondary outcomes. Levels of statistical significance will also be presented. Finally in chapter five (Discussion and Conclusions) will provide a discussion of the strength and weaknesses of the study and its implications for practice. Conclusions which may reasonably be drawn from this trial will be presented along with the limitations of these conclusions. Directions for future studies will then be briefly addressed. -- Following the body of the text there will be a full set of appendices illustrating the documentation used in the study prior to the bibliography and references.

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