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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00340-47 |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
Incomplete spontaneous abortion (ISA) is defined by the intrauterine retention of conceptual product after incomplete or partial expulsion of the conceptual product. Treatment such retention may be expectant care, medical treatment or surgery. Currently, curettage is the standard surgical treatment in most centers. However, operative hysteroscopy, in addition to the direct visualization of the retained conceptual product, in contrast to the curettage, would allow elective evacuation of retention while reducing surgical complications. Studies of low effective, retrospective, have found an fertility's increase in patients treated by operative hysteroscopy. These data need to be confirmed by a randomized controlled trial in order to change the standard surgical treatment of this disease if hysteroscopy procedure would found to be superior.
We propose a multicenter - single blind - randomized - therapeutic study. Randomization will concern the surgical procedure in patients treated surgically for intrauterine retention after spontaneous miscarriage. Randomization will be performed at the admission to the patient in the operating room by electronic means using a secure internet platform, single-blind for the patient with unblinding at the end of the trial or in case of complication. The patient will be randomly assigned to one of two treatment arms following:
Patients will have a care in accordance with center practices for the hospital stay. Surgical treatment will be performed within the time depending on the availability of the operating room of participating center.
A hospitalization report indicating the participation to the study, but not mentioning the treatment group, will be sent to the attending physician and the patient. An information form with postoperative instructions will be given to patients included in this protocol without mentioning the surgical arm. The operative report will be given to the patient at the end of her participation in the trial.
A total of five visits (including final visit) are scheduled for this trial. The patient will be monitored in the form of telephone conversation or questionnaire sent by email or post. Monitoring will be done by the investigator that enrolled the patient with the help of the URC in charge of the project. In case of complications, failure of the intervention or diagnosis of a uterine cavity pathology, the care will be left to the discretion of the medical center team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : Operative hysteroscopy | Experimental | operative hysteroscopy with direct visualization |
|
| Arm B : Aspirative curettage | Active Comparator | curettage is the standard surgical treatment in most centers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive intrauterine pregnancy > 22 WA | Questionnaire | Until 2 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Next pregnancy | Until 2 years post surgery | |
| Surgical complications' rate | Clavien-Dindo classification | until 2 years post surgery |
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Inclusion Criteria:
Exclusion Criteria:
Will not be included in the protocol patients :
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud FAUCONNIER, MD, PhD | Centre Hospitalier Intercommunal de Poissy / Saint-Germain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier intercommunal de poissy-saint germain en Laye | Poissy | 78300 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37039805 | Result | 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. | |
| 26282937 |
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| ID | Term |
|---|---|
| D000027 | Abortion, Incomplete |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| D003475 | Curettage |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| Curettage | Procedure | 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. |
|
| Surgical reinterventions |
| until 2 years post surgery |
| Huchon 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. |
| 34061352 | Derived | Ghosh 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. |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |