NCT02515604CompletedPhase 4
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure - a Randomized Clinical Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Wolfson Medical Center
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)
Study Overview
Brief Summary
A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Single dose group
Active Comparator
Intervention: Misoprostol (Drug)
Repeated dose group
Active Comparator
Intervention: Misoprostol (Drug)
Outcomes
Primary Outcomes
Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)
Time Frame: Day 8 from first misoprostol dose
Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yossi Mizrachi
MD
Wolfson Medical Center
Study Sites (1)
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