Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention

NARecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

September 18, 2023

Primary Completion Date

July 1, 2026

Study Completion Date

January 1, 2029

Conditions
Miscarriage
Interventions
PROCEDURE

hysteroscopy

The procedure is performed by a gynecologic surgeon under general or spinal anesthesia, depending on the standard practice of the center involved, with the patient in the gynecologic position. Antibiotic prophylaxis may be administered according to the standard practice of the center. The equipment available at each center will be used for operative hysteroscopy. The use of energy is usually unnecessary and saline will be preferred. Before the operation, the appearance of the uterine cavity will be described. The selected design product will be resected from top to bottom using the surgical resector, without electrical energy, as this method is known to be the most protective of the endometrium in previous studies. Electric current should be used only as a last resort, in cases where the selected design cannot be removed without it. If there is active bleeding after the procedure, elective coagulation via the hysteroscope may be performed to stop intrauterine bleeding.

PROCEDURE

Aspiration

The aspiration will be performed by a gynecological surgeon, according to the center's standard protocol. A flexible or rigid cannula can be used. Antibiotic prophylaxis, the diameter of the cannula used, the cervical preparation required, and the use of intraoperative ultrasound guidance will be left to the discretion of the operator and the standard practice of the center. In most centers, the cervix is dilated with a Hegar dilator of up to 9 mm in size.

Trial Locations (4)

30029

RECRUITING

CHU de Nîmes - Hôpital Carémeau, Nîmes

33000

RECRUITING

CHU de Bordeaux - Hôpital Pellegrin, Bordeaux

34295

RECRUITING

CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier

06202

NOT_YET_RECRUITING

CHU de Nice - Hôpital Archet II, Nice

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER