Status:
RECRUITING
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Medtronic
Conditions:
Retained Products of Conception
Eligibility:
FEMALE
18-39 years
Phase:
NA
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 p...
Detailed Description
Design : RCT * Multicenter * Randomized controlled * Parallel group design * Superiority trial * Non-blinded Primary Objective To compare the effectiveness in terms of time to next pregnancy betwee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04804332
Start Date
July 12 2021
End Date
December 30 2027
Last Update
May 14 2024
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000