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Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention

ConditionMiscarriage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known uterine malformation

Patient who has received surgical treatment for current intrauterine retention

Patient with an intrauterine device (IUD)

Pregnancy obtained by medically assisted procreation

Trial design

Design model

Parallel

Treatments tested in this trial

  • hysteroscopy

    Procedure/Surgery

    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.

  • Aspiration

    Procedure/Surgery

    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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Arm A: HysteroscopyExperimental treatment 1 intervention
Group B: Arm B: AspirationExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 weeks after surgery

Secondary outcomes

1

Difference between the two arms in complication rates

Complications will be described according to clavien-dindo classification

Time frame
During surgery and 6 weeks after surgery
2

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

The rate of second line surgical management will be described

Time frame
During surgery
3

Difference between the two arms in synechia rates

Presence of synechia will be assessed by hysterosonography

Time frame
6 weeks after surgery
4

Difference between the two arms in mean time to conception

Patients will be contacted by phone at 6, 12 and 24 months after the surgery to ask if they have been pregnant et evaluate the time of conception

Time frame
6, 12 and 24 months after surgery

Other outcomes

Sponsors and contacts

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University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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