A Prospective Study Evaluating the Impact of Conservative... | NCT06862089

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

NCT06862089

Sponsor

Fu Xing Hospital, Capital Medical University

Status

Recruiting

Last Update Posted

Jun 15, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Retained Products of Conception
Miscarriage
Conservative Management

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2024Actual

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Feb 12, 2025

First Submission Date that Met QC Criteria

Mar 2, 2025

First Posted Date

Mar 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2025

Last Update Posted Date

Jun 15, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huang Rui, MD,Gynecologist, Department of Hysteroscopy Center, Fu Xing Hospital, Capital Medical UniversityPrincipal Investigator

Lead Sponsor

Fu Xing Hospital, Capital Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
the disappearance rate of EMV	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rui Huang	Contact	+86 18610317613		blueberry0801@foxmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hysteroscopy Center, Fuxing Hospital, Capital Medical University	Recruiting	Beijing		100086	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

all IPD that underlie results in a publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000022	Abortion, Spontaneous

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided