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

NCT07534982 | Recruiting

• 1 other identifier: 0056-24MMC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retained Product of Conception After First Trimester Medical Abortion

Keywords

RPOC

Outcome Measures

Primary Outcomes (1)

• Evaluate effectiveness of medical management

  Evaluate the effectiveness of medical management with misoprostol and expectant management for retained products of conception (RPOC) following medical abortion for delayed miscarriage in the first trimester (up to 12 weeks).

  From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks.

Secondary Outcomes (1)

• Assess the complication of expectant versus medical management of RPOC.

  From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks

Study Arms (2)

• Participants will be randomized into two groups: medical management with misoprostol and expectant

NO INTERVENTION

expectant management (observation only).

medical management

EXPERIMENTAL

medical management with misoprostol

Drug: medical management with misoprostol

Interventions

medical management with misoprostol DRUG

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.

medical management

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yael Yagur: lead
• Meir Hospital, Kfar Saba, Israel: collaborator

Study Sites (1)

Meir Medical Center

Kfar Saba, 4861027, Israel

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Chen Manor Bar, MD

CONTACT

+972544414211; Manor.chen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Yael Yagur

Model Details: * Prospective study involving women diagnosed with RPOC following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester. * Participants will be randomized into two groups: medical management with misoprostol and expectant management (observation only). * Data will be collected through three follow-up visits over six weeks, with ultrasound evaluations to monitor uterine content and decide on further interventions, if necessary.

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: April 16, 2026
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)