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

NCT06862089 | Recruiting

• 1 other identifier: 2024FXHEC-KSP073
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Retained Products of Conception; Miscarriage; Conservative Management

Outcome Measures

Primary Outcomes (1)

• The disappearance rate of RPOC

  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 Outcomes (1)

• the disappearance rate of EMV

  Immediately after the completion of conservative treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Hysteroscopy Center, Fuxing Hospital, Capital Medical University

Beijing, 100086, China

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Rui Huang

CONTACT

+86 18610317613; blueberry0801@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Gynecologist, Department of Hysteroscopy Center

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 6, 2025
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)