The “PRIM” study: A randomized comparison of prostaglandin E2 gel with the nitric oxide donor isosorbide mononitrate for cervical ripening before the induction of labor at term - 18/08/11
Reprint requests: Jane E. Norman, Division of Developmental Medicine, Reproductive and Maternal Medicine Section, University of Glasgow, 3rd Floor, Queen Elizabeth Building, Glasgow Royal Infirmary, 10 Alexandra Parade, Glasgow, G31 2ER, United Kingdom.Abstract |
Objective |
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.
Study design |
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.
Results |
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.
Conclusion |
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.
Le texte complet de cet article est disponible en PDF.Key words : Induction of labor, Nitric oxide donors, Prostaglandins, Cervical ripening
Plan
| Supported by a grant from the Sir Jules Thorn Charitable Trust (reference no. 01/02 A). |
Vol 194 - N° 4
P. 1012-1021 - avril 2006 Retour au numéro
Article précédent
- Is planned vaginal delivery for breech presentation at term still an option? Results of an observational prospective survey in France and Belgium
- François Goffinet, Marion Carayol, Jean-Michel Foidart, Sophie Alexander, Serge Uzan, Damien Subtil, Gérard Bréart, for the PREMODA Study Group
- Intravaginal glyceryl trinitrate and dinoprostone for cervical ripening and induction of labor
- Filomena P. Nunes, Ana P. Campos, Sónia R. Pedroso, Cristina F. Leite, Teresa P. Avillez, Rosalinda D. Rodrigues, Manuel Meirinho
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?