A Prospective Multicenter Observational Real-world Study of Retained Products of Conception

February 11, 2026 updated by: Xu dabao, The Third Xiangya Hospital of Central South University
The purpose of this study is to explore the optimal treatment strategy for retained products of pregnancy. Compared with surgical treatment, prospectively observe whether drug-assisted expectant management until the right time for surgery reduce the occurrence of intrauterine adhesions, and thus protect fertility.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third XIANGYA Hospital of Central South University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

From June 2022 to June 2024, patients diagnosed with retained products of conception by ultrasound in the outpatient department.

Description

Inclusion Criteria:Clinical diagnosis of retained products of conception, and ultrasound indicated that the maximum diameter of the lesion ≥0.5cm.

Exclusion Criteria:1) There is active bleeding requiring immediate surgical intervention;2) combined with obvious infection;3) Combined with severe organ dysfunction, including coagulation dysfunction.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
After the patient is confirmed to be included in the study, he/she will be hospitalized directly and will undergo hysteroscopic removal of pregnancy products.
Procedure: Uterine curettage
Use intravenous general anesthesia (which can be assisted by laryngeal mask) (local anesthesia, epidural anesthesia or endotracheal intubation anesthesia can be selected in special cases), the patient takes the lithotomy position, the anesthesia effect is satisfactory, and the uterine distension fluid is normal saline. The uterine distension pressure is adjusted to maintain at 100-120 mmHg. It is recommended to use a diagnostic and therapeutic integrated hysteroscope with an outer diameter of <5 mm (it is necessary to record the specific type of hysteroscope and instrument used) to enter the uterine cavity through the cervix to clarify the situation in the uterine cavity. Then explore the depth of the uterus. (Under ultrasonic monitoring) The cervical dilator sequentially dilates the cervix to 8-10 (depending on the outer diameter of the therapeutic hysteroscope used, hysteroscopic electroresection is not recommended), and select a 7mm outer diameter hysteroscope with a 3mm diameter.
Experimental group
Wait until a certain time, then surgical treatment if necessary
Drug: Expectant care
Patients with no contraindications to medication should take 2mg Bid of Progynova (or a similar dose of Estoril) orally until after surgery (generally, Progynova is still used for about 2-4 weeks after surgery and progesterone withdrawal bleeding is used); take Yimucao granules or Wujia Biochemical Capsules orally for 2 weeks and then stop taking the medicine; check blood β-HCG every week; check uterine and bilateral adnexa 4D color Doppler ultrasound every 2-3 weeks; until the preset surgery time is reached: 1) blood β-HCG <50mmol/L; 2) B-ultrasound measurement of the length from the internal cervical os to the uterine fundus ≤6cm; 3) the time interval from the previous surgery is at least 4 weeks; 4) Color Doppler ultrasound indicates that the blood flow level of the pregnancy and the attachment is 1-3.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment
Time Frame: At 3 months after completion of treatment (on the 16th-24th day of the third menstrual cycle post-treatment)
Intrauterine adhesions are diagnosed by three-dimensional transvaginal ultrasound or hysteroscopy. Adhesions are graded according to the American Fertility Society (AFS) classification. This outcome measures the incidence of IUA following different management strategies for retained products of conception, reflecting the degree of endometrial injury.
At 3 months after completion of treatment (on the 16th-24th day of the third menstrual cycle post-treatment)
Number of Participants Requiring Secondary Surgical Evacuation
Time Frame: From initiation of treatment to 3 months post-treatment
Secondary surgical evacuation is defined as any additional surgical procedure (hysteroscopic or curettage) required for complete removal of retained products of conception after the initial management strategy. This outcome reflects the effectiveness of the initial treatment approach and the number of intrauterine procedures.
From initiation of treatment to 3 months post-treatment
Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception
Time Frame: From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year
Pregnancy is defined as a positive serum β-hCG test and confirmed intrauterine gestational sac by ultrasound. This outcome is assessed only in participants with fertility intent and reflects the ultimate goal of fertility preservation.
From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Active Bleeding During Expectant Management
Time Frame: From enrollment to hospitalization or intervention, assessed up to 3 months
Active bleeding is defined as vaginal bleeding exceeding twice the normal menstrual volume, requiring emergency hospitalization or surgical intervention during the expectant management period. This outcome reflects the safety of expectant management.
From enrollment to hospitalization or intervention, assessed up to 3 months
Number of Participants with Pelvic Infection During Expectant Management
Time Frame: From enrollment to hospitalization or intervention, assessed up to 3 months
Pelvic infection is defined as the presence of clinical signs (fever, pelvic pain, purulent discharge) and/or laboratory evidence (elevated white blood cell count, CRP, procalcitonin) requiring antibiotic therapy or surgical intervention. This outcome reflects the safety of expectant management.
From enrollment to hospitalization or intervention, assessed up to 3 months
Number of Participants with Live Birth Following Subsequent Pregnancy
Time Frame: At delivery, assessed up to 1 year after pregnancy confirmation
Live birth is defined as the delivery of any viable infant (≥24 weeks of gestation). This outcome is the most definitive measure of reproductive outcome following treatment.
At delivery, assessed up to 1 year after pregnancy confirmation
Intraoperative Blood Loss During Hysteroscopic Surgery
Time Frame: During the surgical procedure
Estimated blood loss (in mL) during hysteroscopic removal of retained products of conception. This outcome reflects surgical complexity and the invasiveness of the procedure.
During the surgical procedure
Endometrial Thickness at 3 Months Post-Treatment
Time Frame: At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment)
Endometrial thickness (in mm) measured by three-dimensional transvaginal ultrasound during the mid-luteal phase. This outcome serves as a surrogate marker of endometrial recovery and receptivity.
At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Third Xiangya Hospital of Central South University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hunan Provincial People's Hospital
ZhuZhou Central Hospital
The First People's Hospital of Huaihua
Xiangtan Central Hospital
Hengyang Central Hospital
The First People's Hospital of Changde City
The First Affiliated Hospital of Shaoyang University
Yongzhou Center Hospital
Changsha Hospital for Maternal and Child Health Care
Changsha Maternal and Child Health Hospital
Liuyang People's Hospital
Xiangtan Hospital for Maternal and Child Health Care
Yiyang Hospital for Maternal and Child Health Care
The First People's Hospital of YueYang
Chenzhou Hospital for Maternal and Child Health Care

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • fkky2022001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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