NCT04804332 Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
| NCT ID | NCT04804332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Retained Products of Conception |
| Study Type | INTERVENTIONAL |
| Enrollment | 244 participants |
| Start Date | 2021-07-12 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 244 participants in total. It began in 2021-07-12 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients after first trimester miscarriage treated non-surgically with sonographic evidence for the presence of RPOC at follow-up visit after 6 weeks (± 1 week) who have an immediate future pregnancy wish and are willing to give informed consent. Exclusion Criteria: * Women aged below 18 years * Women aged over 39 years * Women not wanting to achieve pregnancy within the first 6 months after non-surgical treatment for miscarriage * Women with a history of repeated miscarriage defined as 3 or more consecutive pregnancy losses before 20 weeks of pregnancy duration * Women with untreated and/or untreatable subfertility * Women presenting with severe uterine bleeding, defined as uterine bleeding that needs acute intervention on medical grounds * Women presenting with severe abdominal pain, defined as abdominal pain that needs acute intervention on medical grounds * Women with fever (\> 38.5° Celsius) or sepsis requiring antibiotic treatment. For the definition of 'sepsis' we refer to the Third International Consensus definitions for Sepsis and Septic Shock (Singer 2016) * Women with a contraindication for (office) operative hysteroscopy * Women with a failed non-surgical management for miscarriage, as substantiated by the sonographic finding of an intact gestational sac still in situ * Women with a congenital uterine anomaly * Known cervical stenosis making safe uterine access impossible * Visual or pathological (e.g. on biopsy) evidence of malignancy
Contact & Investigator
Tjalina Hamerlynck, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT04804332 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying Retained Products of Conception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04804332 currently recruiting?
Yes, NCT04804332 is actively recruiting participants. Contact the research team at eline.meireson@uzgent.be for enrollment information.
Where is the NCT04804332 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT04804332 clinical trial?
NCT04804332 is sponsored by University Hospital, Ghent. The principal investigator is Tjalina Hamerlynck, MD PhD at University Hospital, Ghent. The trial plans to enroll 244 participants.