Actively Recruiting
Hysteroscopy Versus Endouterine Aspiration in Managing Trophoblastic Retention After Early Miscarriage: A Prospective Randomized Multicenter Study
Led by University Hospital, Montpellier · Updated on 2025-01-01
220
Participants Needed
4
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying treatment options for women experiencing incomplete early miscarriage, where some pregnancy tissue remains in the uterus after an early miscarriage. This condition can cause ongoing bleeding and infection, increasing distress for patients. The study aims to compare two surgical methods, hysteroscopy and endo-uterine aspiration, to see which is more effective at clearing retained tissue six weeks after surgery, using ultrasound for evaluation. Participants will be randomly assigned to one of two groups: one receiving operative hysteroscopy performed by a gynecologic surgeon under anesthesia, and the other undergoing endo-uterine aspiration using a cannula. Both groups may receive misoprostol and antibiotic prophylaxis before surgery, and anti-adhesion gels may be applied to reduce scarring. Additional care includes treatment for infections if needed and preventative care for Rh-negative women. The study involves multiple centers and standardized protocols. Participants will have a pre-operative consultation for eligibility and consent, followed by surgery on the assigned day. Follow-up includes a six-week post-surgery visit with ultrasound and hysterosonography to check uterine emptiness and scar tissue, plus phone consultations at 6, 12, and 24 months to assess fertility and time to conception. Researchers will monitor complications, need for additional surgery, and pregnancy outcomes over two years. The total participation may last up to 26 months after surgery.
CONDITIONS
Brief Title
Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women managed for trophoblastic retention after early spontaneous miscarriage (less than 14 weeks of amenorrhea)
- Diagnosis of intrauterine trophoblastic retention by endovaginal pelvic ultrasound
- Shared decision to have surgical management
- Currently desire pregnancy
You will not qualify if you...
- Known uterine malformation
- Previous surgical treatment for current intrauterine retention
- Trophoblastic retention after elective termination, late miscarriage, or postpartum
- Use of an intrauterine device (IUD)
- Pregnancy obtained by medically assisted procreation
- Emergency surgical management needed for bleeding control
- Unable to provide free, informed, written consent
- Not covered by a national health insurance system
- Under legal protection such as guardianship or curatorship
- Participating in other interventional research involving humans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 to 21 days before the operation
Participants are screened for eligibility to participate in the trial.
1 pre-operative consultation (in-person)
Duration - Day of the operation
Participants undergo surgical management of trophoblastic retention by either operative hysteroscopy or endo-uterine aspiration.
1 surgical procedure visit (in-person)
Duration - 6 weeks after surgery (+/- 7 days)
Participants are monitored after surgery with ultrasound and hysterosonography to assess uterine vacuity and synechiae, and complications are recorded.
1 follow-up consultation visit (in-person)
Duration - 6 months to 24 months after surgery
Participants are followed up by telephone to evaluate fertility and time to conception up to 24 months after surgery.
3 telephone consultations at 6, 12, and 24 months after surgery
Trial Site Locations
Total: 4 locations
1
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
2
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Actively Recruiting
3
CHU de Nice - Hôpital Archet II
Nice, France, 06202
Not Yet Recruiting
4
CHU de Nîmes - Hôpital Carémeau
Nîmes, France, 30029
Actively Recruiting
Research Team
M
Martha DURAES, MD
E
Elodie GUIBERT, CRA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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