Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
HY-PER
Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
2 other identifiers
interventional
577
1 country
1
Brief Summary
The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 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
July 17, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2014
CompletedStudy Start
First participant enrolled
November 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2020
CompletedSeptember 5, 2025
August 1, 2025
5 years
July 17, 2014
August 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progressive intrauterine pregnancy > 22 WA
Questionnaire
Until 2 years post surgery
Secondary Outcomes (3)
Next pregnancy
Until 2 years post surgery
Surgical complications' rate
until 2 years post surgery
Surgical reinterventions
until 2 years post surgery
Study Arms (2)
Arm A : Operative hysteroscopy
EXPERIMENTALoperative hysteroscopy with direct visualization
Arm B : Aspirative curettage
ACTIVE COMPARATORcurettage is the standard surgical treatment in most centers
Interventions
Performed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
Performed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage.
Eligibility Criteria
You may qualify if:
- Major, under 45 years with intrauterine trophoblastic retention after incomplete miscarriage in the first quarter (termination of pregnancy \< 14 WA),
- With desire of pregnancy ;
- Intrauterine trophoblastic retention diagnosed by transvaginal pelvic ultrasound finding a intrauterine heterogeneous image or intrauterine gestational sac more than 15 mm in thickness, complicated or not of endometritis ;
- Decision to surgical management of incomplete miscarriage by the health care team ;
- Patient beneficiary or affiliated to a health insurance
- Informed and signed consent
You may not qualify if:
- Will not be included in the protocol patients :
- having a uterine malformation known ;
- having received surgical treatment for the current intrauterine retention ;
- with intrauterine retention diagnosed by transvaginal pelvic ultrasound of more than 50 mm in thickness ;
- requiring a haemostatic act in urgency for heavy vaginal bleeding (miscarriage haemorrhage) ;
- bearer of intrauterine device ;
- having an evolutive pregnancy;
- having an ectopic pregnancy;
- having a trophoblastic retention following a voluntary abortion ;
- having a pregnancy achieved by medically assisted procreation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier intercommunal de poissy-saint germain en Laye
Poissy, 78300, France
Related Publications (3)
Huchon C, Drioueche H, Koskas M, Agostini A, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Panel P, Raiffort C, Giraudet G, Bussieres L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1197-1205. doi: 10.1001/jama.2023.3415.
PMID: 37039805BACKGROUNDHuchon C, Koskas M, Agostini A, Akladios C, Alouini S, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Matheron I, Panel P, Raiffort C, Fauconnier A. Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial. Trials. 2015 Aug 19;16:363. doi: 10.1186/s13063-015-0900-1.
PMID: 26282937BACKGROUNDGhosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PMID: 34061352DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arnaud FAUCONNIER, MD, PhD
Centre Hospitalier Intercommunal de Poissy / Saint-Germain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2014
First Posted
July 28, 2014
Study Start
November 5, 2014
Primary Completion
November 15, 2019
Study Completion
July 3, 2020
Last Updated
September 5, 2025
Record last verified: 2025-08