Status:
COMPLETED
The HYsteroscopic Miscarriage MaNagement Trial: A Pilot RCT Investigating a Novel Management Pathway for RPOC
Lead Sponsor:
Birmingham Women's and Children's NHS Foundation Trust
Collaborating Sponsors:
Tommy's
Conditions:
Retained Products After Miscarriage
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Pregnancy tissue can be found remaining in the womb in up to 20% of women following a miscarriage. These "retained products of conception" (RPOC), which are diagnosed by transvaginal ultrasound, can c...
Detailed Description
The diagnosis of retained products of conception (RPOC) following miscarriage causes physiological and emotional stress to women and their partners. Additional hospital visits, inpatient admissions an...
Eligibility Criteria
Inclusion
- Women above 18 years
- Women choosing either expectant or medical management of a first-trimester miscarriage ≤14 weeks gestation
- Women wanting to conceive as soon as possible after their miscarriage
- Consent to trial processes: (1) undergo follow-up with transvaginal ultrasound for the investigation of RPOC; (2) be randomised to outpatient hysteroscopy for confirmation and treatment or standard management; (3) accept trial follow up procedures - questionnaires, telephone interviews
Exclusion
- Women below 18 years
- Women with findings suspicious of gestational trophoblastic disease
- Women with fever (≥38°C) or sepsis secondary to genital tract infection/endometritis
- Women who are unable to understand spoken and written English
Key Trial Info
Start Date :
January 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04751500
Start Date
January 31 2021
End Date
November 2 2022
Last Update
August 14 2023
Active Locations (1)
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1
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG