Retained Products of ConceptionNCT07421895
A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
An observational study of Retained Products of Conception and RPOC, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retained Products of Conception, RPOC
- What is being tested?
- Uterine curettage and Expectant care
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: From June 2022 to June 2024, patients diagnosed with retained products of conception by ultrasound in the outpatient department.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Dabao MD, 13017386201, forxudabao@126.com
About this study
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.
- Conditions
- Retained Products of Conception, RPOC
- Being tested
- Uterine curettage, Expectant care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine curettageProcedure or surgery
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.
Expectant careDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Uterine curettage | |
| Experimental group | Wait until a certain time, then surgical treatment if necessary Receives: Drug: Expectant care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Intrauterine Adhesions (IUA) at 3 Months 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.
Measured: 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
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.
Measured: From initiation of treatment to 3 months post-treatment
Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception
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.
Measured: From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year
Secondary outcomes (5)
Number of Participants with Active Bleeding During Expectant Management
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.
Measured: From enrollment to hospitalization or intervention, assessed up to 3 months
Number of Participants with Pelvic Infection During Expectant Management
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.
Measured: From enrollment to hospitalization or intervention, assessed up to 3 months
Number of Participants with Live Birth Following Subsequent Pregnancy
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.
Measured: At delivery, assessed up to 1 year after pregnancy confirmation
Intraoperative Blood Loss During Hysteroscopic Surgery
Estimated blood loss (in mL) during hysteroscopic removal of retained products of conception. This outcome reflects surgical complexity and the invasiveness of the procedure.
Measured: During the surgical procedure
Endometrial Thickness at 3 Months 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.
Measured: At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jun 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products of ConceptionStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Changsha Hospital for Maternal and Child Health Care, ZhuZhou Central Hospital, Xiangtan Central Hospital, Xiangtan Hospital for Maternal and Child Health Care, Yiyang Hospital for Maternal and Child Health Care, The First People's Hospital of YueYang, The First People's Hospital of Changde City, The First Affiliated Hospital of Shaoyang University, Hunan University of Medicine General Hospital, Hengyang Central Hospital, Chenzhou Hospital for Maternal and Child Health Care, Yongzhou Center Hospital, Hunan Provincial People's Hospital, Changsha Maternal and Child Health Hospital, Liuyang People's Hospital
- Responsible party
- Principal investigator, Xu dabao, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421895
- Sponsor's protocol ID
- fkky2022001
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
- ClinicalTrials.gov ID
- NCT07421895
- Acronym / sponsor ID
- fkky2022001
- Conditions
- Retained Products of Conception, RPOC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Changsha Hospital for Maternal and Child Health Care, ZhuZhou Central Hospital, Xiangtan Central Hospital, Xiangtan Hospital for Maternal and Child Health Care, Yiyang Hospital for Maternal and Child Health Care, The First People's Hospital of YueYang, The First People's Hospital of Changde City, The First Affiliated Hospital of Shaoyang University, Hunan University of Medicine General Hospital, Hengyang Central Hospital, Chenzhou Hospital for Maternal and Child Health Care, Yongzhou Center Hospital, Hunan Provincial People's Hospital, Changsha Maternal and Child Health Hospital, Liuyang People's Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Procedure: Uterine curettageAfter the patient is confirmed to be included in the study, he/she will be hospitalized directly and will undergo hysteroscopic removal of pregnancy products. |
| Experimental group | – | Drug: Expectant careWait until a certain time, then surgical treatment if necessary |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- From June 2022 to June 2024, patients diagnosed with retained products of conception by ultrasound in the outpatient department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine curettageUse 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. | Procedure or surgery | Control group |
| Expectant carePatients 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. | Drug | Experimental group |
Primary outcome
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.
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.
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.
5 secondary outcomes
Number of Participants with Active Bleeding During Expectant Management
Time frame: 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
Number of Participants with Live Birth Following Subsequent Pregnancy
Time frame: At delivery, assessed up to 1 year after pregnancy confirmation
Intraoperative Blood Loss During Hysteroscopic Surgery
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Retained Products of Conception
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
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Intracervical Vasopressin
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Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
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Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retained Products of Conception and RPOC, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dabao MD (13017386201, forxudabao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.