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

NCT07421895 | Recruiting

• 1 other identifier: fkky2022001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retained Products of Conception; RPOC

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  From enrollment to hospitalization or intervention, assessed up to 3 months

• Number of Participants with Pelvic Infection During Expectant Management

  From enrollment to hospitalization or intervention, assessed up to 3 months

• Number of Participants with Live Birth Following Subsequent Pregnancy

  At delivery, assessed up to 1 year after pregnancy confirmation

• Intraoperative Blood Loss During Hysteroscopic Surgery

  During the surgical procedure

• Endometrial Thickness at 3 Months Post-Treatment

  At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment)

Study Arms (2)

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

Experimental group

Wait until a certain time, then surgical treatment if necessary

Drug: Expectant care

Interventions

Uterine curettage PROCEDURE

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.

Control group

Expectant care DRUG

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

Sponsors & Collaborators

• The First People's Hospital of YueYang: collaborator
• The First People's Hospital of Changde City: collaborator
• The Third Xiangya Hospital of Central South University: lead
• Changsha Hospital for Maternal and Child Health Care: collaborator
• ZhuZhou Central Hospital: collaborator
• Xiangtan Central Hospital: collaborator
• Xiangtan Hospital for Maternal and Child Health Care: collaborator
• Yiyang Hospital for Maternal and Child Health Care: collaborator
• The First Affiliated Hospital of Shaoyang University: collaborator
• The First People's Hospital of Huaihua: collaborator
• Hengyang Central Hospital: collaborator
• Chenzhou Hospital for Maternal and Child Health Care: collaborator
• Yongzhou Center Hospital: collaborator
• Hunan Provincial People's Hospital: collaborator
• Changsha Maternal and Child Health Hospital: collaborator
• Liuyang People's Hospital: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

Vacuum Curettage

Intervention Hierarchy (Ancestors)

Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Dabao MD

CONTACT

13017386201; forxudabao@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: February 19, 2026
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 19, 2026

Record last verified: 2025-05

Locations

CN (1)