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

Обзор

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.

Вмешательства

• Процедура 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 \<
• Препарат 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

Первичные конечные точки

• Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment [Срок оценки: 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 [Срок оценки: From initiation of treatment to 3 months post-treatment]
• Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception [Срок оценки: From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year]

Вторичные конечные точки (5)

• Number of Participants with Active Bleeding During Expectant Management [Срок оценки: From enrollment to hospitalization or intervention, assessed up to 3 months]
• Number of Participants with Pelvic Infection During Expectant Management [Срок оценки: From enrollment to hospitalization or intervention, assessed up to 3 months]
• Number of Participants with Live Birth Following Subsequent Pregnancy [Срок оценки: At delivery, assessed up to 1 year after pregnancy confirmation]
• Intraoperative Blood Loss During Hysteroscopic Surgery [Срок оценки: During the surgical procedure]
• Endometrial Thickness at 3 Months Post-Treatment [Срок оценки: At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• The Third Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07421895 · fkky2022001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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