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

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.

Study Overview

• Status: Recruiting
• Conditions: Retained Product of Conception After First Trimester Medical Abortion
• Intervention / Treatment: Drug: medical management with misoprostol

Detailed Description

Study Goals:

• Primary Objectives: 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).
• Secondary Objectives: Assess the safety and complications of expectant versus medical management of RPOC.

Study Design:

• 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.

Population:

Women aged 18-45 diagnosed with delayed miscarriage up to 12 weeks gestation, with sonographic evidence of RPOC after medical abortion using mifepristone and misoprostol.

Inclusion Criteria:

1. Age 18-45.
2. RPOC identified on ultrasound after medical abortion, defined as endometrial thickness >10 mm with Doppler flow into the uterine cavity.
3. Hemodynamically stable women with bleeding comparable to menstrual flow, without fever.

Exclusion Criteria:

1. Hemodynamic instability, excessive bleeding, or fever.
2. Endometrial thickness >40 mm.
3. Endometrial thickness <10 mm without Doppler flow into the cavity.
4. Presence of a gestational sac within the uterine cavity.
5. Women who received two doses of misoprostol before evaluation. Study Duration:Five years.

Sample Size:

Based on previous studies, 124 women (62 per group) are required for 80% power at a 5% significance level. Accounting for potential attrition, a total of 150 participants will be recruited (75 in each group).

Data Collection:

• Demographic data (age, ethnicity, weight, height).
• Medical history (chronic conditions, medications).
• Obstetric and gynecologic history.
• Current pregnancy details (gestational age, method of conception).
• Sonographic data at diagnosis and follow-ups (endometrial thickness, RPOC dimensions, Doppler flow parameters).
• Complications during the process (surgical interventions, blood transfusions, infections, intrauterine adhesions).

Statistical Analysis:

Data will be analyzed using SPSS software. ANOVA will assess differences between groups on outcomes.

Confidentiality:

All data will be anonymized and stored securely, with access limited to the primary and co-investigators. Data will be retained for 15 years.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Manor Bar, MD; Phone Number: +972544414211; Email: manor.chen@gmail.com

Study Locations

• Israel
  • Kfar Saba, Israel, 4861027
    • Recruiting
    • Meir Medical Center
    • Contact: Chen Manor Bar, MD; Phone Number: +972544414211; Email: manor.chen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-45.
2. RPOC identified on ultrasound after medical abortion, defined as endometrial thickness >10 mm with Doppler flow into the uterine cavity.
3. Hemodynamically stable women with bleeding comparable to menstrual flow, without fever.

Exclusion Criteria:

1. Hemodynamic instability, excessive bleeding, or fever.
2. Endometrial thickness >40 mm.
3. Endometrial thickness <10 mm without Doppler flow into the cavity.
4. Presence of a gestational sac within the uterine cavity.
5. Women who received two doses of misoprostol before evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: • Participants will be randomized into two groups: medical management with misoprostol and expectant; expectant management (observation only).
Experimental: medical management; medical management with misoprostol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the complication of expectant versus medical management of RPOC.	infection, uterine adhesions	From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks

Collaborators and Investigators

• Sponsor: Yael Yagur
• Collaborators: Meir Hospital, Kfar Saba, Israel

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: RPOC
• Additional Relevant MeSH Terms: Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E, Synthetic; Misoprostol
• Other Study ID Numbers: 0056-24MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No