Management of RPOC After Induced Abortion

Phase 4

Completed

• Conditions: Abortion Induced Complicated
• Interventions: Drug: Misoprostol

• Registration Number: NCT04685694
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

Inclusion Criteria

• 18 < age < 45 year old
• Thick irregular endometrium >12 mm on trans-vaginal ultrasound

Exclusion Criteria

• Endometritis
• Cervical opening > 1 cm
• Uterine abnormalities
• Contraindication to Misoprostol treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical	Misoprostol	SL 800 mcg Misoprostol

Primary Outcome Measures

Name	Time	Method
RPOC rate	2 months	RPOC rate in repeat ultrasound scan performed 5 weeks after randomization

Secondary Outcome Measures

Name	Time	Method
Adhesions	2 months	According to our study protocol all women with persistent products of conception diagnosed on repeated ultrasound examination undergo hysteroscopy. During hysteroscopy, assessment of the uterine cavity including intrauterine adhesion formation will be performed. Intrauterine adhesions will be classified according to the American Society for Reproductive Medicine (ASRM), based on the extent of cavity involvement (\<1/3; 1/3 to 2/3, \>2/3) and the type of adhesion seen (filmy, filmy and dense, dense).
Bleeding	2 months	Bleeding pattern will be assessed via questionnaire upon recruitment and follow up visits. Bleeding will be characterized by its pattern (regular, intermenstrual) and quantity (normal, hypomenorrhoea, menorrhagia).

Trial Locations

Locations (1)

Tel Aviv Medical Center; ,; 🇮🇱 Tel Aviv, Israel