Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2024
CompletedMarch 30, 2023
March 1, 2023
2 years
January 10, 2021
March 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Retained product of conception (RPOC)
2 months
Study Arms (3)
Operative Hysteroscopy
EXPERIMENTALHysteroscopic separation
Dilation and Curettage
ACTIVE COMPARATORCurettage separation
Feasibility and safety
EXPERIMENTALThe first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase
Interventions
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
Operative hysteroscopy - safety and feasibility phase
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- women who electively choose to terminate pregnancy
- women who took medical treatment for missed abortion prior to recruitment
- women with known uterine abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Related Publications (6)
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.
PMID: 10864550BACKGROUNDWang 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.
PMID: 12620443BACKGROUNDAmerican 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.
PMID: 30157093BACKGROUNDZhang 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.
PMID: 16120856BACKGROUNDHooker 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.
PMID: 24082042BACKGROUNDSalzani 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.
PMID: 18094891BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yariv Yogev, M.D.
Tel-Aviv Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director Research & Development
Study Record Dates
First Submitted
January 10, 2021
First Posted
January 12, 2021
Study Start
January 21, 2022
Primary Completion
January 20, 2024
Study Completion
January 20, 2024
Last Updated
March 30, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- within 6 months of completion
- Access Criteria
- Yes
Study protocol and statistical analysis plan