Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention

NCT05789940 | Recruiting

• 1 other identifier: RECHMPL22_0397
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

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

Conditions

Miscarriage

Keywords

Miscarriage; Hysteroscopy; Aspiration; Fertility; Synechiae

Outcome Measures

Primary Outcomes (1)

• Uterine vacuity

  Uterine vacuity will be determined by endovaginal pelvic ultrasound. The endovaginal pelvic ultrasound will be performed by an investigator blinded to the patient's group, in order to minimize bias. It will be performed according to a standard pelvic ultrasound technique: a sagittal section and a transverse section passing through the widest part of the uterine body. Uterine vacuity will be defined by a thickness of the mucosa on a sagittal section of 15 mm or less and the absence of a heterogeneous intrauterine mass

  6 weeks after surgery

Secondary Outcomes (5)

• Difference between the two arms in complication rates

  During surgery and 6 weeks after surgery

• Difference between the two arms in the rate of second line surgical management

  During surgery

• Difference between the two arms in synechia rates

  6 weeks after surgery

• Difference between the two arms in mean time to conception

  6, 12 and 24 months after surgery

• Difference between the two arms in pregnancy rates

  6, 12 and 24 months after surgery

Study Arms (2)

Arm A: Hysteroscopy

EXPERIMENTAL

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.

Procedure: hysteroscopy

Arm B: Aspiration

EXPERIMENTAL

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.

Procedure: Aspiration

Interventions

hysteroscopy PROCEDURE

The procedure is performed by a gynecologic surgeon under general or spinal anesthesia, depending on the standard practice of the center involved, with the patient in the gynecologic position. Antibiotic prophylaxis may be administered according to the standard practice of the center. The equipment available at each center will be used for operative hysteroscopy. The use of energy is usually unnecessary and saline will be preferred. Before the operation, the appearance of the uterine cavity will be described. The selected design product will be resected from top to bottom using the surgical resector, without electrical energy, as this method is known to be the most protective of the endometrium in previous studies. Electric current should be used only as a last resort, in cases where the selected design cannot be removed without it. If there is active bleeding after the procedure, elective coagulation via the hysteroscope may be performed to stop intrauterine bleeding.

Arm A: Hysteroscopy

Aspiration PROCEDURE

The aspiration will be performed by a gynecological surgeon, according to the center's standard protocol. A flexible or rigid cannula can be used. Antibiotic prophylaxis, the diameter of the cannula used, the cervical preparation required, and the use of intraoperative ultrasound guidance will be left to the discretion of the operator and the standard practice of the center. In most centers, the cervix is dilated with a Hegar dilator of up to 9 mm in size.

Arm B: Aspiration

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (4)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

RECRUITING

CHU de Nice - Hôpital Archet II

Nice, 06202, France

NOT YET RECRUITING

CHU de Nîmes - Hôpital Carémeau

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Martha DURAES, MD

  CHU de Montpellier

  STUDY DIRECTOR

Central Study Contacts

Martha DURAES, MD

CONTACT

+334 67 33 65 32; m-duraes@chu-montpellier.fr

Elodie GUIBERT, CRA

CONTACT

+334 67 33 53 17; elodie.guibert@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)