Vaginal Misoprostol and Foley Catheter for Induction of Labor

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

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-02-28

Brief Summary

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to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

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Detailed Description

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two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Conditions

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Induction of Labor Affected Fetus / Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sequential

sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

vaginal Misoprostol Plus Foley Catheter

Foley Catheter

Intervention Type DEVICE

Concurrent

Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

vaginal Misoprostol Plus Foley Catheter

Foley Catheter

Intervention Type DEVICE

Interventions

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Misoprostol

vaginal Misoprostol Plus Foley Catheter

Intervention Type DRUG

Foley Catheter

Intervention Type DEVICE

Other Intervention Names

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cytotec

Eligibility Criteria

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Inclusion Criteria

* Indication for labour induction Term pregnancy with alive fetus Bishop score less than five

Exclusion Criteria

* Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes