Oral Versus Vaginal Misoprostol for Induction of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148473
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 8, 2005
Information provided by:
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Termed Pregnancy With Indications for Labor Induction. Drug: Misoprostol Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor: A Randomized Controlled Trial
Study Start Date : March 2000
Study Completion Date : October 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Primary Outcome Measures :
  1. The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148473

BMA Medical College and Vajira Hospital
Bangkok, Thailand, 10300
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Principal Investigator: Manit Sripramote, MD BMA Medical College and Vajira Hospital Identifier: NCT00148473     History of Changes
Other Study ID Numbers: VJR-01
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 8, 2005
Last Verified: September 2005

Keywords provided by Bangkok Metropolitan Administration Medical College and Vajira Hospital:
Cervical ripening.
Induction of labor.

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents