Hysteroscopy Versus Endouterine Aspiration in the Management of Trophoblastic Retention: A Prospective Randomized Multicenter Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU de Montpellier - Hôpital Arnaud de Villeneuve
RECRUITING
Montpellier
CHU de Nice - Hôpital Archet II
NOT_YET_RECRUITING
Nice
CHU de Nîmes - Hôpital Carémeau
RECRUITING
Nîmes
Contact Information
Primary
Martha DURAES, MD
m-duraes@chu-montpellier.fr
+334 67 33 65 32
Backup
Elodie GUIBERT, CRA
elodie.guibert@chu-montpellier.fr
+334 67 33 53 17
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 220
Treatments
Experimental: Arm A: Hysteroscopy
Patients randomized to the hysteroscopy arm will receive misoprostol antibiotic prophylaxis to dilate the cervix before surgery, and anti-adhesion barrier gels will be used, according to routine procedures at each center. In case of intrauterine retention complicated by endometritis, antibiotic treatment for 48 hours (penicillin, metronidazole, fluoroquinolones or a combination of these antibiotics) will be administered according to the standard practice of each center. Evacuated retention product will be sent for pathological examination. Rh-negative women will receive prophylaxis to prevent Rh alloimmunization.
Experimental: Arm B: Aspiration
Patients randomized to the aspiration arm will receive misoprostol antibiotic prophylaxis to dilate the cervix before surgery and anti-adhesion barrier gels will be used, according to routine procedures at each center. In case of intrauterine retention complicated by endometritis, antibiotic treatment for 48 hours (penicillin, metronidazole, fluoroquinolones or a combination of these antibiotics) will be administered according to the standard practice of each center. Evacuated retention product will be sent for pathological examination. Rh-negative women will receive prophylaxis to prevent Rh alloimmunization.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov