A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conc… (NCT06862089) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV
China120 participantsStarted 2024-10-23
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The disappearance rate of RPOC
Timeframe: 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
Trial details
NCT IDNCT06862089
SponsorFu Xing Hospital, Capital Medical University