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New treatment option for Retained Products of Conception
Official title Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT04804332
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39, women only
You may be able to join if
- Patients after first trimester miscarriage treated non-surgically with sonographic evidence for the presence of RPOC at follow-up visit after 6 weeks...
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.