A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV

Recruiting

• Conditions: Retained Products of Conception; Miscarriage; Conservative Management

• Registration Number: NCT06862089
• Lead Sponsor: Fu Xing Hospital, Capital Medical University

Brief Summary

The goal of this observational study is to learn about the therapeutic effects of the conservative treatment approach on pepole with retained products of conception (RPOC) and Enhanced myometrial vascularity (EMV).

The main question it aims to answer is: Is it possible to achieve the natural resolution of RPOC by combining it with EMV through conservative treatment？ Participants will receive conservative treatment (such as mifepristone, GnRH-a, or expectant management) following the initial diagnosis of RPOC and EMV, and the therapeutic efficacy of the conservative approach will be assessed after the completion of two menstrual cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-23
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-03-02
• Study First Posted: 2025-03-06
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Recent history of miscarriage or delivery (within the past 8 weeks)
• Strong willingness to undergo conservative management
• Hemodynamically stable
• Signed informed consent form

Exclusion Criteria

• Heavy vaginal bleeding (requiring immediate surgical intervention)
• Active pelvic or systemic infection (e.g., fever >38°C, elevated CRP/WBC)
• Severe dysfunction of vital organs (heart, liver, or kidney)
• Known drug allergies or contraindications to proposed medications (e.g., misoprostol intolerance)
• Suspected ectopic pregnancy or gestational trophoblastic disease (confirmed by ultrasound or β-hCG levels)
• Placenta accreta spectrum disorders diagnosed during current pregnancy
• History of uterine artery embolization

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The disappearance rate of RPOC	After conservative treatment, transvaginal ultrasound was performed at the end of the second menstrual cycle (calculated from the first day of menses, 28-30 days per cycle) to assess RPOC resolution	The definition of "the disappearance rate of RPOC" refers to the absence of significant residual trophoblastic tissue as indicated by ultrasound examination

Secondary Outcome Measures

Name	Time	Method
the disappearance rate of EMV	Immediately after the completion of conservative treatment	The definition of "the disappearance rate of EMV" refers to a PSV (Peak Systolic Velocity) of less than 20 cm/s or its complete disappearance as indicated by Ultrasound Doppler examination.

Trial Locations

Locations (1)

Hysteroscopy Center, Fuxing Hospital, Capital Medical University; 🇨🇳 Beijing, China