Comparing hysteroscopy and aspiration for managing retained tissue after miscarriage
Hysteroscopy Versus Endouterine Aspiration in the Management of Trophoblastic Retention: A Prospective Randomized Multicenter Study
NA · University Hospital, Montpellier · NCT05789940
This study tests which method, hysteroscopy or aspiration, works better to remove leftover tissue after a miscarriage and helps women feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT05789940 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two surgical techniques, hysteroscopy and endo-uterine aspiration, in managing trophoblastic retention following early miscarriage. The study will assess outcomes at six weeks post-surgery using endovaginal ultrasound to determine which method is more effective in clearing retained tissue. Additionally, it will compare complication rates and the need for further surgical interventions between the two approaches. The trial is designed to provide clearer guidance for clinicians and patients in choosing the appropriate management strategy.
Who should consider this trial
Good fit: Ideal candidates for this study are women under 14 weeks of pregnancy who have experienced a spontaneous miscarriage and have been diagnosed with intrauterine trophoblastic retention.
Not a fit: Patients with known uterine malformations, those who have had previous surgical treatment for intrauterine retention, or those with specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management options for women experiencing incomplete miscarriages, reducing complications and psychological distress.
How similar studies have performed: While there is limited direct comparison data, previous studies have shown varying success with both hysteroscopy and aspiration techniques in similar contexts, indicating the need for this head-to-head evaluation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 3 other locations
- CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (RECRUITING)
- CHU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier, France (RECRUITING)
- CHU de Nice - Hôpital Archet II — Nice, France (NOT_YET_RECRUITING)
- CHU de Nîmes - Hôpital Carémeau — Nîmes, France (RECRUITING)
Study contacts
- Study coordinator: Martha DURAES, MD
- Email: m-duraes@chu-montpellier.fr
- Phone: +334 67 33 65 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Miscarriage, Hysteroscopy, Aspiration, Fertility, Synechiae