Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
The Success Rate After Expectant & Medical Management for a Retained Product of Conception After Medical Termination of Pregnancy in First Trimester Spontaneous Abortion-RCT
Yael Yagur
150 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
Summary
This prospective randomized controlled trial evaluates the success of medical versus expectant management for retained products of conception (RPOC) following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester. Women aged 18-45 with sonographic evidence of RPOC (endometrial thickness \>10 mm with Doppler flow) will be randomized into two groups: medical management with misoprostol or expectant management (observation only). Follow-up will include ultrasound evaluations over six weeks to monitor uterine clearance and determine further interventions. Population: 150 participants, with 75 in each group. Inclusion Criteria: Stable women with RPOC after medical abortion, bleeding comparable to menstrual flow, and no fever. Exclusion Criteria: Hemodynamic instability, excessive bleeding, fever, or specific endometrial thickness criteria. Outcome Measures: RPOC resolution, need for surgical intervention, complications, and sonographic changes. Study Duration: Five years. Data on demographics, medical history, and ultrasound findings will be analyzed using SPSS, with results informing optimal management strategies for RPOC after first-trimester medical abortion.
Eligibility
Inclusion Criteria3
- Age 18-45.
- RPOC identified on ultrasound after medical abortion, defined as endometrial thickness >10 mm with Doppler flow into the uterine cavity.
- Hemodynamically stable women with bleeding comparable to menstrual flow, without fever.
Exclusion Criteria5
- Hemodynamic instability, excessive bleeding, or fever.
- Endometrial thickness >40 mm.
- Endometrial thickness <10 mm without Doppler flow into the cavity.
- Presence of a gestational sac within the uterine cavity.
- Women who received two doses of misoprostol before evaluation.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Following the diagnosis of RPOC after a missed abortion managed with a medical abortion protocol, medical management will involve administering 800 mg of misoprostol as per our departmental guidelines.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07534982