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Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.

RecruitingNAAges 18 Years - 39 YearsFemaleUniversity Hospital, Ghent
NCT04804332 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Operative hysteroscopy
  • Expectant management
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Where

1 site
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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