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NCT Number: NCT06862089

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Hysteroscopy Center, Fuxing Hospital, Capital Medical University

Beijing, 100086, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fu Xing Hospital, Capital Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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