Oral Versus Vaginal Misoprostol for Induction of Labor

Termed Pregnancy With Indications for Labor Induction. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148473
• Other study ID #: VJR-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: March 2000
• Est. completion date: October 2001

Study information

• Verified date: September 2005
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Termed Pregnancy With Indications for Labor Induction.

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
Thailand	BMA Medical College and Vajira Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.
Secondary	Rate of vaginal delivery within 24 hours.
Secondary	Cesarean section rate.
Secondary	Uterine tachysystole.
Secondary	Uterine hyperstimulation syndrome.
Secondary	Number of women received oxytocin.
Secondary	Neonatal outcomes.