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Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Primary Purpose

Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Operative Hysteroscopy
D&C
Operative Hysteroscopy - safety and feasibility
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spontaneous Abortion

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Lis Maternity Hospital, Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Operative Hysteroscopy

Dilation and Curettage

Feasibility and safety

Arm Description

Hysteroscopic separation

Curettage separation

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Retained product of conception (RPOC)
RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment

Full Information

First Posted
January 10, 2021
Last Updated
March 27, 2023
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04705324
Brief Title
Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion
Official Title
Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion, Retained Products of Conception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative Hysteroscopy
Arm Type
Experimental
Arm Description
Hysteroscopic separation
Arm Title
Dilation and Curettage
Arm Type
Active Comparator
Arm Description
Curettage separation
Arm Title
Feasibility and safety
Arm Type
Experimental
Arm Description
The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase
Intervention Type
Procedure
Intervention Name(s)
Operative Hysteroscopy
Intervention Description
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
D&C
Intervention Description
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
Intervention Type
Procedure
Intervention Name(s)
Operative Hysteroscopy - safety and feasibility
Intervention Description
Operative hysteroscopy - safety and feasibility phase
Primary Outcome Measure Information:
Title
Intrauterine adhesions (IUA)
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Retained product of conception (RPOC)
Description
RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yossi Tzur, M.D.
Phone
+97236925603
Email
yossitzur@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gilad Rattan, M.D.
Phone
+97236925603
Email
giladrattan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yariv Yogev, M.D.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yariv Yogev, MD
Phone
97236925603
Email
yarivyogev@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yossi Tzur, MD
Phone
97236925603
Email
yossitzur@gmail.com
First Name & Middle Initial & Last Name & Degree
Yogev Yariv, MD
First Name & Middle Initial & Last Name & Degree
Gilad Rattan, MD
First Name & Middle Initial & Last Name & Degree
Yossi Tzur, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and statistical analysis plan
IPD Sharing Time Frame
within 6 months of completion
IPD Sharing Access Criteria
Yes
Citations:
PubMed Identifier
10864550
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.
Results Reference
background
PubMed Identifier
12620443
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.
Results Reference
background
PubMed Identifier
30157093
Citation
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.
Results Reference
background
PubMed Identifier
16120856
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.
Results Reference
background
PubMed Identifier
24082042
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.
Results Reference
background
PubMed Identifier
18094891
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.
Results Reference
background

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Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

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