An interventional study of Operative hysteroscopy and Expectant management in Retained Products of Conception, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
Rationale: Elective immediate dilation and curettage (D\&C) for miscarriage is associated with the occurrence of intrauterine adhesions (IUA). IUAs may be associated with subsequent subfertility and premature birth. Recent studies have shown that in women with miscarriage, medical treatment (misoprostol/mifepristone) is an effective alternative for curettage. A problem with medication and expectant management is that after initial treatment, sonographic findings during follow-up frequently show incomplete evacuation of uterine retained products of conception (RPOC), which often lead to additional interventions or expectant time-consuming management limiting the benefits of medical treatment.
Objective: To assess, in women with a wish for immediate future pregnancy and RPOC after non-surgical management of a miscarriage, as diagnosed with sonography, the effects of operative hysteroscopy versus expectant management.
Study design: Multicenter randomized clinical trial. Study population: Patients after non-surgical management of a miscarriage with sonographic evidence of RPOC at the follow-up visit 6 weeks after initial treatment and wish for immediate (within 6 months) future pregnancy.
Intervention: operative hysteroscopy versus expectant management. Main study parameters/endpoints: The primary outcome is time to next pregnancy, as substantiated by a positive urinary or serum hCG test. Secondary outcomes are Quality of Life (QOL) scores assessed with the SF-36, HADS and EQ-5D-5L, the need for additional and/or unscheduled treatments and/or visits and complications. Furthermore, data on the course of pregnancy - including miscarriage, ectopic pregnancy and live birth - are documented in those women who have an ongoing pregnancy after randomization during the study follow up period. In addition, iMTA PCQ questionnaires and health-costs are measured in all patients to perform a cost-effectiveness analysis.
A total of 244 (122 per arm) women will be sufficient to answer the questions on the primary endpoint.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women participating in the study will be asked to fill out questionnaires at baseline, 8 weeks and 6 months after randomization. We don not expect specific risks as a result of either the intervention or expectant management.
Design : RCT
Primary Objective
To compare the effectiveness in terms of time to next pregnancy between operative hysteroscopy and expectant management in patients with sonographic evidence of RPOC after primary non-surgical management of miscarriage.
Secondary Objectives
Effectiveness objectives
To compare the effectiveness between operative hysteroscopy and expectant management with respect to:
Safety objectives
To compare the safety between operative hysteroscopy and expectant management with respect to:
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No treatment will be offered.
Other: Expectant management
Operative hysteroscopy using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) is performed.
Procedure: Operative hysteroscopy
Operative hysteroscopy is performed without or under local, regional or general anesthesia according to the local protocol preferably within 2 to 3 weeks after randomization. In case of highly vascularized RPOC, a repeat sonogram is performed 2 to 4 weeks after randomization to check for persistence of vascularity and to optimize operative timing. Operative hysteroscopy is then performed within 2 to 3 weeks after the repeat sonogram. Removal of the RPOC is performed by an experienced gynecologist using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) and according to the local protocol.
No treatment will be offered. Patients will be given telephone numbers to contact a doctor. In case of severe complaints, defined as heavy uterine bleeding and/or severe abdominal pain, not responding to conservative treatment, an emergency curettage or operative hysteroscopy may be performed.
Time to next pregnancy
The primary endpoint is the time until next pregnancy since randomization, with pregnancy defined as a positive urinary or serum hCG test. Patients are asked to contact the study team in case of pregnancy. If a participant has failed to contact the center, pregnancy will be asked at same time as the questionnaires and then once every 6 months as well as at the end of the study by telephone contact or e-mail.
Time frame: up to 3 years after the start of the trial
Quality Of Life (QOL)
measured by SF-36
Time frame: at baseline, 8 weeks after randomization and 6 months after randomization
Quality Of Life (QOL)
measured by HADS (Hospital Anxiety and Depression Scale)
Time frame: at baseline, 8 weeks after randomization and 6 months after randomization
Quality Of Life (QOL)
measured by EQ-5D-5L
Time frame: at baseline, 8 weeks after randomization and 6 months after randomization
Course of pregnancy
Course of pregnancy in those women who have an ongoing pregnancy after randomization during the study follow-up period (including miscarriage, ectopic pregnancy and live birth): * Time to conception, defined as the time from randomization to the date of conception retrospectively determined based on the crown-rump length measurement (CRL) by a first-trimester ultrasound. * Clinical pregnancy defined as a pregnancy diagnosed by ultrasonographic visualization of 1 or more gestational sacs or definitive clinical signs of pregnancy, including ectopic pregnancy. Multiple gestational sacs are counted as 1 clinical pregnancy. * Live birth, defined as the complete expulsion or extraction from the mother of a product of fertilization, irrespective of the duration of pregnancy, which after such separation breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been
Time frame: up to 3 years after the start of the trial
Necessity for additional treatment
Necessity for additional treatment
Time frame: until 6 months after randomisation
Out-of-protocol/unscheduled visits
Re-interventions or additional treatment during the first 6 months including type, number and reasons. Out-of-protocol visits to the outpatient clinic or general practitioner or hospitalizations including type, number, reasons and duration of hospitalization.
Time frame: until 6 months after randomisation
Complications
Heavy uterine bleeding defined as uterine bleeding that needs acute intervention (IV iron administration, tranexamic acid or blood transfusion) on medical grounds
Time frame: until 6 months after randomisation
Complications
Severe abdominal pain requiring analgesics or medical intervention, excluding postoperative pain in the first 48 hours after uterine surgery
Time frame: until 6 months after randomisation
Complications
Fever (\>38.5° Celsius) or sepsis
Time frame: until 6 months after randomisation
Complications
\- Related to operative hysteroscopy or other surgical treatment * uterine perforation * postoperative hemorrhage, defined as excessive blood loss estimated or measured as ≥ 500 mL and/or need for blood transfusion * severe abdominal pain requiring analgesics excluding postoperative pain in the first 48 hours after hysteroscopic surgery * fluid overload (defined as absorption of more than 2500 mL of distention medium with clinical consequences for the patient) * electrolyte disturbances requiring treatment * gas embolism
Time frame: until 6 months after randomisation
Health related costs
the EQ-5D-5L and health-related costs based on physician visits, hospitalizations and emergency room visits are measured
Time frame: until 6 months after randomisation
Plan to share: No
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University Hospital, Ghent