Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07421895

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Retained Products of Conception RPOC

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Dabao MD

CONTACT

[email protected]

13017386201

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dabao MD

CONTACT

[email protected]

13017386201

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • Changsha Hospital for Maternal and Child Health Care
  • Changsha Maternal and Child Health Hospital
  • Chenzhou Hospital for Maternal and Child Health Care
  • Hengyang Central Hospital
  • Hunan Provincial People's Hospital
  • Hunan University of Medicine General Hospital
  • Liuyang People's Hospital
  • The First Affiliated Hospital of Shaoyang University
  • The First People's Hospital of Changde City
  • The First People's Hospital of YueYang
  • Xiangtan Central Hospital
  • Xiangtan Hospital for Maternal and Child Health Care
  • Yiyang Hospital for Maternal and Child Health Care
  • Yongzhou Center Hospital
  • ZhuZhou Central Hospital

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.