Combined Method for Induction of Labor

February 12, 2016 updated by: Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

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
      • Cairo, Egypt, 12211
        • Recruiting
        • Kasr El Aini Hospital
        • Principal Investigator:
          • Dina M Dakhly, MD
        • Contact:

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:

  • females presenting for induction of labor

Exclusion Criteria:

  • previous cesarean section
  • previous uterine scars e.g. myomectomy
  • refusal to participate in the study

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
in this group misoprostol 25 ug will be administrated for induction of labor every 6 hours
Drug: Misoprostol ( Prostaglandin E2)
Other Names:
  • Cytotec
Experimental: Foley's catheter
In this group foley's catheter 30 cc will be used for induction of labor
Device: Foley's catheter
Experimental: Combined
Both misoprostol 25 ug and foley's catheter will be used for induction
Drug: Misoprostol ( Prostaglandin E2)
Other Names:
  • Cytotec
Device: Foley's catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of induction of labor
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Woman's Health University Hospital, Egypt

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

February 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM0702116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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