Back to resultsMisoprostol for Second Trimester Pregnancy Termination (MIS)
Primary Purpose
Intra Uterine Fetal Death
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
termination of second trimester pregnancy
Sponsored by
About this trial
This is an interventional treatment trial for Intra Uterine Fetal Death
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
extra amniotic misoprostol
vaginal misoprostol
Arm Description
misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours)
misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours)
Outcomes
Primary Outcome Measures
mean duration from the initial misoprostol dose until complete fetal expulsion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02669420
Brief Title
Misoprostol for Second Trimester Pregnancy Termination
Acronym
MIS
Official Title
Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra Uterine Fetal Death
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
extra amniotic misoprostol
Arm Type
Experimental
Arm Description
misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours)
Arm Title
vaginal misoprostol
Arm Type
Experimental
Arm Description
misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours)
Intervention Type
Procedure
Intervention Name(s)
termination of second trimester pregnancy
Intervention Description
Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial
Primary Outcome Measure Information:
Title
mean duration from the initial misoprostol dose until complete fetal expulsion
Time Frame
24 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34061352
Citation
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
Results Reference
derived
Learn more about this trial
Misoprostol for Second Trimester Pregnancy Termination
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