Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention

Summary

Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists.

Aim: The main objective is to compare the efficacy of management by endo-uterine aspiration vs. management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound.

Methods: This is a prospective, multicenter, randomized, open-label, two-arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage.

Patients will be randomized (110 per arm) after verification of eligibility criteria and signature of consent, on the day of the operation:

* Arm A: 110 patients treated by operative hysteroscopy
* Arm B: 110 patients treated by endo-uterine aspiration

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.

Sponsors & Collaborators

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Martha DURAES, MD · CHU de Montpellier

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-18

Primary Completion

2026-07-01

Completion

2029-01-01

Countries

• France

Study Locations