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Oral Versus Vaginal Misoprostol for Induction of Labor

This study has been completed.
Sponsor:
Information provided by:
Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier:
NCT00148473
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Termed Pregnancy With Indications for Labor Induction.
 Drug: Misoprostol
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor: A Randomized Controlled Trial

Resource links provided by NLM:

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

Further study details as provided by Bangkok Metropolitan Administration Medical College and Vajira Hospital:

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

Secondary Outcome Measures:
  • Rate of vaginal delivery within 24 hours.
  • Cesarean section rate.
  • Uterine tachysystole.
  • Uterine hyperstimulation syndrome.
  • Number of women received oxytocin.
  • Neonatal outcomes.

Estimated Enrollment: 180
Study Start Date: March 2000
Estimated Study Completion Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148473

Locations
Thailand
BMA Medical College and Vajira Hospital
Bangkok, Thailand, 10300
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Investigators
Principal Investigator: Manit Sripramote, MD BMA Medical College and Vajira Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00148473     History of Changes
Other Study ID Numbers: VJR-01
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Thailand: Food and Drug Administration

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

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 18, 2013