Vaginal Misoprostol and Foley Catheter for Induction of Labor

June 14, 2017 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sequential
sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.
Device: Foley Catheter
Drug: Misoprostol
vaginal Misoprostol Plus Foley Catheter
Other Names:
  • cytotec
Active Comparator: Concurrent
Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.
Device: Foley Catheter
Drug: Misoprostol
vaginal Misoprostol Plus Foley Catheter
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction delivery interval (time from starting induction to delivery)
Time Frame: 48hours
safety issue
48hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need of oxytocin for augmentation of labour
Time Frame: 48h
safety issue
48h
Number of doses needed to bring on labour
Time Frame: 48h
safety issue
48h
Failed induction (failure to elicit contraction after 72 hours)
Time Frame: 72h
safety issue
72h
Hyperstimulation syndrome
Time Frame: 24h
safety issue
24h
Cesarean section
Time Frame: 72h
safety issue
72h
Severe neonatal morbidity or perinatal death
Time Frame: 28 days
safety issue
28 days
Serious maternal morbidity or maternal death
Time Frame: 42 days
safety issue
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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