Actively Recruiting

Phase Not Applicable
Age: 18Years - 42Years
FEMALE
ID05789940

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

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 1 to 21 days before the operation

Participants are screened for eligibility to participate in the trial.

1 pre-operative consultation (in-person)

Treatment

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)

Follow-up

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)

Long-term Monitoring

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

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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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