Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

March 27, 2023 updated by: Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D&C) in the management of first trimester missed abortion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Operative Hysteroscopy
Hysteroscopic separation
Procedure: Operative Hysteroscopy
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
Active Comparator: Dilation and Curettage
Curettage separation
Procedure: D&C
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
Experimental: Feasibility and safety
The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase
Procedure: Operative Hysteroscopy - safety and feasibility
Operative hysteroscopy - safety and feasibility phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrauterine adhesions (IUA)
Time Frame: 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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retained product of conception (RPOC)
Time Frame: 2 months
RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2022

Primary Completion (Anticipated)

January 20, 2024

Study Completion (Anticipated)

January 20, 2024

Study Registration Dates

First Submitted

January 10, 2021

First Submitted That Met QC Criteria

January 10, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0087-20-TLV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and statistical analysis plan

IPD Sharing Time Frame

within 6 months of completion

IPD Sharing Access Criteria

Yes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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