NCT04685694

Management of RPOC After Induced Abortion

Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion

Detailed description

An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.

Conditions

• Abortion Induced Complicated

Interventions

Type	Name	Description
DRUG	Misoprostol	sl 800 mcg misoprostol

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2020-12-28
• Last updated: 2022-05-03

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study