Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure
Primary Purpose
Abortion, Missed
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Missed
Eligibility Criteria
Inclusion Criteria:
- Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
- Age equal or greater than 18 years
- Gestational age less than 12 complete weeks.
Exclusion Criteria:
- Complete, incomplete, inevitable, or septic abortion.
- Hemodynamically unstable patients.
- Misoprostol sensitivity or contraindication.
- Multifetal pregnancies.
Sites / Locations
- Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single dose group
Repeated dose group
Arm Description
Outcomes
Primary Outcome Measures
Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)
Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.
Secondary Outcome Measures
Full Information
NCT ID
NCT02515604
First Posted
August 2, 2015
Last Updated
October 31, 2016
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02515604
Brief Title
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure
Official Title
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure - a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose group
Arm Type
Active Comparator
Arm Title
Repeated dose group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Primary Outcome Measure Information:
Title
Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)
Description
Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.
Time Frame
Day 8 from first misoprostol dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
Age equal or greater than 18 years
Gestational age less than 12 complete weeks.
Exclusion Criteria:
Complete, incomplete, inevitable, or septic abortion.
Hemodynamically unstable patients.
Misoprostol sensitivity or contraindication.
Multifetal pregnancies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yossi Mizrachi, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
28402415
Citation
Mizrachi Y, Dekalo A, Gluck O, Miremberg H, Dafna L, Feldstein O, Weiner E, Bar J, Sagiv R. Single versus repeat doses of misoprostol for treatment of early pregnancy loss-a randomized clinical trial. Hum Reprod. 2017 Jun 1;32(6):1202-1207. doi: 10.1093/humrep/dex074.
Results Reference
derived
Learn more about this trial
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure
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