Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT04804332
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT04804332
Study Brief:
Protocol Section:
NCT04804332