Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy

February 6, 2018 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

Low Dose Vaginal Misoprostol With or Without Foley Catheter for Late Second Trimester Pregnancy Termination in Women With Previous Multiple Cesarean Sections

Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.

Study Type

Interventional

Enrollment (Actual)

97

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:late second trimester

  • IUFD
  • Previous Multiple Cesarean Sections

Exclusion Criteria:Low lying placenta

  • asthma
  • allergy to misoprostol
  • patient refuse to participate

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal Misoprosto
Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section
Drug: MisoprostoL
Vaginal MisoprostoL
Other Names:
  • CYTOTEC
Active Comparator: Misoprostol Plus Foley Catheter
Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections
Drug: MisoprostoL
Vaginal MisoprostoL
Other Names:
  • CYTOTEC
Device: Foley Catheter
Misoprostol Plus Foley Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction to expulsion interval
Time Frame: 24 hours
from time to start induction to time of complete expulsion of product of conception
24 hours

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 (Actual)

January 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zuh- 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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