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Completed

NCT Number: NCT00148473

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.

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

BMA Medical College and Vajira Hospital

Bangkok, 10300, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A live singleton pregnancy at a gestation of >37 weeks, with obstetric or medical indications for induction, and unfavorable cervix (the initial Bishop score of <717), vertex presentation, reactive fetal heart rate pattern, absence of labor, and intact membranes without previous stripping. Post-term inductions were considered when gestational age was >41 weeks.

Exclusion criteria

  • Suspected cephalo-pelvic disproportion, estimated fetal weight of >4000 grams, maternal age of <18 years, parity of >5, previous cesarean delivery or history of uterine incision, any contraindication for vaginal delivery or prostaglandins administration and suspected chorioamnionitis.

Treatment and study plan

Misoprostol

Drug

Primary outcomes

  1. The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.

Secondary outcomes

  1. Rate of vaginal delivery within 24 hours.

  2. Cesarean section rate.

  3. Uterine tachysystole.

  4. Uterine hyperstimulation syndrome.

  5. Number of women received oxytocin.

  6. Neonatal outcomes.

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor: A Randomized Controlled Trial

Important dates

Study start
2000
Study completion
2001
First posted
Sep 8, 2005
Registry last updated
Sep 8, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.