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Oral Versus Vaginal Misoprostol for Induction of Labor

NCT ID: NCT00148473

Last Updated: 2005-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2001-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Termed Pregnancy With Indications for Labor Induction.

Keywords

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Cervical ripening. Induction of labor. Misoprostol.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Misoprostol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Manit Sripramote, MD

Role: PRINCIPAL_INVESTIGATOR

BMA Medical College and Vajira Hospital

Locations

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BMA Medical College and Vajira Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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VJR-01

Identifier Type: -

Identifier Source: org_study_id