Oral Versus Vaginal Misoprostol for Induction of Labor
The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.
Termed Pregnancy With Indications for Labor Induction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor: A Randomized Controlled Trial|
- The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.
- Rate of vaginal delivery within 24 hours.
- Cesarean section rate.
- Uterine tachysystole.
- Uterine hyperstimulation syndrome.
- Number of women received oxytocin.
- Neonatal outcomes.
|Study Start Date:||March 2000|
|Estimated Study Completion Date:||October 2001|
Induction of labor is widely carried out all over the world in cases where continuation of pregnancy is hazardous to both the mother and/or fetus. The induction in a ripe cervix is not difficult but complications are significantly increased when the cervix is unripe. The only agent approved for cervical ripening and induction of labor in patients with an unripe cervix is dinoprostone(PGE2). Misoprostol is a synthetic PGE1 analogue marketed for the prevention and treatment of gastro-duodenal ulcers. Misoprostol costs much less than dinoprostone and does not require refrigeration and has few systemic side effects.In addition, it is rapidly absorbed orally and vaginally. Although misoprostol is not registered for such use, it has been widely used for obstetric indications such as induction of abortion and of labor. Misoprostol for induction of labor in preceding literatures mainly prescribed in multiple dosing regimen. The adverse effects on uterus potentially occur owing to the frequent administration of misoprostol. The objective of this study was to compare a single dose oral misoprostol with vaginal misoprostol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148473
|BMA Medical College and Vajira Hospital|
|Bangkok, Thailand, 10300|
|Principal Investigator:||Manit Sripramote, MD||BMA Medical College and Vajira Hospital|