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

June 12, 2025 updated by: Huang Rui, Fu Xing Hospital, Capital Medical University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100086
        • Recruiting
        • Hysteroscopy Center, Fuxing Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population of who visited the outpatient department of the hysteroscopy center of our hospital from October 2024 to October 2026 and were provisionally diagnosed as " retained products of conception (RPOC)" based on their history and symptoms.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The disappearance rate of RPOC
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the disappearance rate of EMV
Time Frame: 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.
Immediately after the completion of conservative treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Xing Hospital, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

March 2, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024FXHEC-KSP073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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