drugset / Trial / NCT00695331
Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.
Timeline
- Start
- 2008-02
- Primary completion
- 2008-12
- Completion
- 2009-01
Outcome
Missed primary endpoint
paper 5.22 hours (3.77-8.58 hours, 25th-75th percentile) in the misoprostol group, and 5.20 hours (3.23-6.50 hours, 25th-75th percentile) in the intravenous oxytocin group (P=.019). PMID 20733443 ↗
paper Complete vaginal delivery occurred within 12 hours for 92 women (78.0%) in the misoprostol group and for 97 women (85.8%) in the oxytocin group (P=.121; relative risk 0.91, 95% confidence interval 0.80-1.03). PMID 20733443 ↗
Publications
- Background Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71.
- Ho M, Cheng SY, Li TC. Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Misoprostol | Other / unclassified | — | Oral |
| Comparator | Oxytocin | Peptide | — | Intravenous |
Indications
No indication recorded.