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RECRUITING
NCT07534982
NA

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

Sponsor: Yael Yagur

View on ClinicalTrials.gov

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.

Official title: The Success Rate After Expectant & Medical Management for a Retained Product of Conception After Medical Termination of Pregnancy in First Trimester Spontaneous Abortion-RCT

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-07-01

Completion Date

2027-07-01

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DRUG

medical management with misoprostol

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)

Meir Medical Center

Kfar Saba, Israel