Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention
Trial Parameters
Brief 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
Eligibility Criteria
Inclusion Criteria: * Management for trophoblastic retention after early spontaneous miscarriage (\<14 weeks of amenorrhea) * Diagnosis of intrauterine trophoblastic retention by endovaginal pelvic ultrasound * Shared decision for surgical management * Current pregnancy desire Exclusion Criteria: * Known uterine malformation * Patient who has received surgical treatment for current intrauterine retention * Trophoblastic retention after elective termination, late miscarriage and postpartum * Patient with an intrauterine device (IUD) * Pregnancy obtained by medically assisted procreation * Indication for emergency surgical management for haemostatic purposes * Failure to obtain free, informed and written consent after a period of reflection * Person not affiliated or beneficiary of a national health insurance system * Person protected by law, under guardianship or curatorship * Person participating in other interventional research involving the human person