NCT05789940 Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention
| NCT ID | NCT05789940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Miscarriage |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2027-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2023-09-18 with a primary completion date of 2027-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Exclusion Criteria: * Known uterine malformation * Patient who has received surgical treatment for current intrauterine retention * 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
Contact & Investigator
Martha DURAES, MD
STUDY DIRECTOR
CHU de Montpellier
Frequently Asked Questions
Who can join the NCT05789940 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying Miscarriage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05789940 currently recruiting?
Yes, NCT05789940 is actively recruiting participants. Contact the research team at m-duraes@chu-montpellier.fr for enrollment information.
Where is the NCT05789940 trial being conducted?
This trial is being conducted at Bordeaux, France, Montpellier, France, Nice, France, Nîmes, France.
Who is sponsoring the NCT05789940 clinical trial?
NCT05789940 is sponsored by University Hospital, Montpellier. The principal investigator is Martha DURAES, MD at CHU de Montpellier. The trial plans to enroll 220 participants.