Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Tel Aviv Sourasky Medical Center

Status: Enrolling

Conditions: Retained Products of Conception; Spontaneous Abortion; Intrauterine Adhesion; Missed Abortion

Treatments: Procedure: D&C; Procedure: Operative Hysteroscopy - safety and feasibility; Procedure: Operative Hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04705324

0087-20-TLV

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

Operative Hysteroscopy

Experimental group

Description:

Hysteroscopic separation

Treatment:

Procedure: Operative Hysteroscopy

Dilation and Curettage

Active Comparator group

Description:

Curettage separation

Treatment:

Procedure: D&C

Feasibility and safety

Experimental group

Description:

The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase

Treatment:

Procedure: Operative Hysteroscopy - safety and feasibility