Misoprostol for Second Trimester Pregnancy Termination (MIS)

January 27, 2016 updated by: abo bakr mitwally, Assiut University

Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial

The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy 13-24 weeks.
  • Women with indication for termination of the pregnancy due to intra uterine fetal death

Exclusion Criteria:-Pregnancy before 13 weeks.

  • Pregnancy beyond 24 weeks.
  • Women with scared uterus.
  • Known hypersensitivity for misoprostol.
  • Refusal of the woman 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: extra amniotic misoprostol
misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours)
Procedure: termination of second trimester pregnancy
Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial
Experimental: vaginal misoprostol
misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours)
Procedure: termination of second trimester pregnancy
Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean duration from the initial misoprostol dose until complete fetal expulsion
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 23, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220 (Other Identifier: Greater Manchester Mental Health NHS Foundation Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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