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NCT04705324 Clinical Trial

Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Intrauterine Adhesion Clinical Trial

Official title:
Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04705324
Other study ID # 0087-20-TLV
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2022
Est. completion date January 20, 2024

Study information
Verified date March 2023
Source Tel-Aviv Sourasky Medical Center
Contact Yossi Tzur, M.D.
Phone +97236925603
Email yossitzur@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 55
Est. completion date January 20, 2024
Est. primary completion date January 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Operative Hysteroscopy
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
• D&C
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
• Operative Hysteroscopy - safety and feasibility
Operative hysteroscopy - safety and feasibility phase

Locations
Country Name City State
Israel Lis Maternity Hospital, Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899. — View Citation

Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29. — View Citation

Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ. 2000 Jun 24;320(7251):1708-12. doi: 10.1136/bmj.320.7251.1708. — View Citation

Salzani A, Yela DA, Gabiatti JR, Bedone AJ, Monteiro IM. Prevalence of uterine synechia after abortion evacuation curettage. Sao Paulo Med J. 2007 Sep 6;125(5):261-4. doi: 10.1590/s1516-31802007000500002. — View Citation

Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0. — View Citation

Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM; National Institute of Child Health Human Development (NICHD) Management of Early Pregnancy Failure Trial. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005 Aug 25;353(8):761-9. doi: 10.1056/NEJMoa044064. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intrauterine adhesions (IUA) 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 Retained product of conception (RPOC) RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment 2 months
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