Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

NCT ID: NCT04705324

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2024-01-20

Brief Summary

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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

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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.

Conditions

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Spontaneous Abortion Missed Abortion Intrauterine Adhesion Retained Products of Conception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative Hysteroscopy

Hysteroscopic separation

Group Type EXPERIMENTAL

Operative Hysteroscopy

Intervention Type PROCEDURE

Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy

Dilation and Curettage

Curettage separation

Group Type ACTIVE_COMPARATOR

D&C

Intervention Type PROCEDURE

Separation of the non-viable gestational sac from the uterine wall through dilation and curettage

Feasibility and safety

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

Group Type EXPERIMENTAL

Operative Hysteroscopy - safety and feasibility

Intervention Type PROCEDURE

Operative hysteroscopy - safety and feasibility phase

Interventions

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Operative Hysteroscopy

Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy

Intervention Type PROCEDURE

D&C

Separation of the non-viable gestational sac from the uterine wall through dilation and curettage

Intervention Type PROCEDURE

Operative Hysteroscopy - safety and feasibility

Operative hysteroscopy - safety and feasibility phase

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eli Sprecher, MD

Deputy Director Research & Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yariv Yogev, M.D.

Role: STUDY_CHAIR

Tel-Aviv Sourasky Medical Center

Locations

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Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yossi Tzur, M.D.

Role: CONTACT

+97236925603

Gilad Rattan, M.D.

Role: CONTACT

+97236925603

Facility Contacts

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Yariv Yogev, MD

Role: primary

97236925603

Yossi Tzur, MD

Role: backup

97236925603

References

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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.

Reference Type BACKGROUND
PMID: 10864550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12620443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30157093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16120856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24082042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18094891 (View on PubMed)

Other Identifiers

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0087-20-TLV

Identifier Type: -

Identifier Source: org_study_id

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