NCT04705324

Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spontaneous Abortion
• Missed Abortion
• Intrauterine Adhesion
• Retained Products of Conception

Interventions

Type	Name	Description
PROCEDURE	Operative Hysteroscopy	Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
PROCEDURE	D&C	Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
PROCEDURE	Operative Hysteroscopy - safety and feasibility	Operative hysteroscopy - safety and feasibility phase

Timeline

• Start date: 2022-01-21
• Primary completion: 2024-01-20
• Completion: 2024-01-20
• First posted: 2021-01-12
• Last updated: 2023-03-30

Locations

1 site across 1 country: Israel