Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Not Applicable

Recruiting

• Conditions: Spontaneous Abortion; Retained Products of Conception; Missed Abortion; Intrauterine Adhesion
• Interventions: Procedure: D&C; Procedure: Operative Hysteroscopy; Procedure: Operative Hysteroscopy - safety and feasibility

• Registration Number: NCT04705324
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D\&C) in the management of first trimester missed abortion.

Detailed Description

A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D\&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.

Study Timeline

• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-10
• Study First Posted: 2021-01-12
• Study Start: 2022-01-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-01-20
• Study Completion: 2024-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP).

Exclusion Criteria

• women who electively choose to terminate pregnancy
• women who took medical treatment for missed abortion prior to recruitment
• women with known uterine abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilation and Curettage	D&C	Curettage separation
Operative Hysteroscopy	Operative Hysteroscopy	Hysteroscopic separation
Feasibility and safety	Operative Hysteroscopy - safety and feasibility	The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase

Primary Outcome Measures

Name	Time	Method
Intrauterine adhesions (IUA)	2 months	IUA formation will be assessed in all participants in the follow up diagnostic hysteroscopy performed 8 weeks after the primary treatment. IUA will be classified according to the American Society for Reproductive Medicine

Secondary Outcome Measures

Name	Time	Method
Retained product of conception (RPOC)	2 months	RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment

Trial Locations

Locations (1)

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel