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Recruiting NCT07421895

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

— Observational Retained Products of Conception RPOC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Uterine curettage, Expectant care.
Who it may be relevant to
Registry conditions: Retained Products of Conception, RPOC. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 \<
  • 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 ti

Primary outcome measures

  • 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)]
  • Number of Participants Requiring Secondary Surgical Evacuation [Time frame: 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]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The Third Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07421895 · fkky2022001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗