The 'PRIM' study: a randomized comparison of prostaglandin E2 gel with the nitric donor isosorbide mononitrate for cervical ripening before the induction of labour at term

Osman, I., Mackenzie, F., Norrie, J., Murray, H., Greer, I.A., Norman, J.E. and Ford, I. (2006) The 'PRIM' study: a randomized comparison of prostaglandin E2 gel with the nitric donor isosorbide mononitrate for cervical ripening before the induction of labour at term. American Journal of Obstetrics and Gynecology, 194(4), pp. 1012-1021. (doi: 10.1016/j.ajog.2005.10.812)

Abstract

<p><b>OBJECTIVE:</b> The purpose of this study was to compare the efficacy and safety profile of prostaglandin E2 with isosorbide mononitrate for cervical ripening before the induction of labor at term.</p> <p><b>STUDY DESIGN:</b> Primigravid women were assigned randomly to receive either 40 mg of isosorbide mononitrate or 2 mg of prostaglandin E2. Efficacy outcomes were the cervical ripening effect of each agent and the time from treatment initiation to delivery. Safety outcomes were the incidence and frequency of maternal side effects and events that would be potentially hazardous for mother and baby during outpatient cervical ripening.</p> <p><b>RESULTS:</b> Prostaglandin E2 was more effective than isosorbide mononitrate in inducing a change in modified Bishop score. Mean duration from treatment initiation to delivery was greater for isosorbide mononitrate than prostaglandin E2. There were no adverse events in the isosorbide mononitrate group that would contraindicate outpatient treatment. However, in the prostaglandin E2 group, 7% of the pregnancies had abnormal fetal heart rate patterns (P = .0002). Maternal satisfaction was significantly higher in the isosorbide mononitrate group.</p> <p><b>CONCLUSION:</b>Although isosorbide mononitrate was less effective, maternal satisfaction was significantly greater. The safety profile of each agent was such that it would be reasonable to give isosorbide mononitrate, but not prostaglandin E2, on an outpatient basis.</p>

• Item Type: Articles
• Additional Information: We thank all the patients who participated in the study, all the doctors and midwives, in particular Sr Noreen Horgan, at the Princess Royal Maternity Hospital, and we thank Dr Philip Owen for reviewing the cardiotocographs and the pharmacists Kay Pollock, Graham Conkie, and June Grant. Lastly, we are grateful to the Chair (IF) and members of the Data and Safety Monitoring Committee: Professor Ian Ford, Dr Andrew Thompson and Dr Lena Macara for their input.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Murray, Mrs Heather and Norrie, Prof John and Ford, Professor Ian and Norman, Professor Jane and Greer, Prof Ian
• Authors: Osman, I., Mackenzie, F., Norrie, J., Murray, H., Greer, I.A., Norman, J.E., and Ford, I.
• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: American Journal of Obstetrics and Gynecology
• ISSN: 0002-9378
• Published Online: 30 March 2006