Actively Recruiting
Removal of Intrauterine Retained Products of Conception After Miscarriage Guided by Hysteroscopy Trial A Randomized Controlled Trial
Led by University Hospital, Ghent · Updated on 2024-05-14
244
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying women who have had a miscarriage treated without surgery but still have retained products of conception (RPOC) visible on ultrasound. The study compares two approaches to managing RPOC in women who want to become pregnant soon after miscarriage. It aims to find out which method leads to a faster next pregnancy and better overall outcomes, including quality of life and pregnancy progress. This randomized clinical trial is conducted at multiple centers and sponsored by University Hospital, Ghent. Participants are randomly assigned to either receive operative hysteroscopy or expectant management. Operative hysteroscopy involves removing retained tissue using a specialized device called the TruClearTM Hysteroscopic Tissue Removal System, typically within 2 to 3 weeks after randomization. In expectant management, no immediate treatment is given, but patients can contact a doctor if severe symptoms occur, with emergency procedures available if needed. Women in the study complete questionnaires about their quality of life at baseline, 8 weeks, and 6 months after randomization. Researchers track the time to next pregnancy up to 3 years, pregnancy outcomes such as miscarriage or live birth, any additional treatments or unscheduled visits, complications, and health-related costs. The study collects detailed data to assess effectiveness, safety, and cost-effectiveness while monitoring participants' health over time.
CONDITIONS
Brief Title
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
- 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 evidence of malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive either operative hysteroscopy performed within 2 to 3 weeks after randomization, or expectant management with no treatment offered. In some cases, a repeat sonogram is performed 2 to 4 weeks after randomization to optimize timing of hysteroscopy.
1 to 3 visits depending on treatment and sonogram requirements
Duration - Up to 3 years
Participants are followed up for safety, quality of life, pregnancy outcomes, and health-related costs up to 3 years after the start of the trial.
Visits at baseline, 8 weeks, 6 months, and periodic follow-up for up to 3 years
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
E
Eline Meireson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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