drugset / Trial / NCT07534982

Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial

NCT07534982

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-01
Primary completion
2027-07-01
Completion
2027-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 800 mg

Indications

No indication recorded.