A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion

Обзор

At present, there is no unified standard for the treatment of missed abortion in clinical practice. This study intends to collect clinical data of this type of disease to compare the efficacy of different treatments, and on this basis, presuppose the synergistic effect of different doses of estrogen in the process of drug induction, conduct statistical analysis of the efficacy, evaluate whether the treatment plan can achieve the therapeutic effect while reducing the occurrence of complications, and provide an effective basis for the subsequent clinical treatment of missed abortion. This study is divided into two parts. The first part is a retrospective analysis to explore the differences between missed abortion surgery and drug treatment, clinical efficacy and reproductive outcomes; the second part is a prospective study to explore the effects of different doses of estrogen combined with surgery or drug abortion on the efficacy of missed abortion in early pregnancy, and explore the best clinical treatment method for missed abortion.

Вмешательства

• Препарат Control group
  No estrogen supplementation
• Препарат Conventional dose of estrogen
  1 day after medical abortion, give oral estradiol valerate, 1 mg Bid, for 21 days, and add dydrogesterone 10 mg Bid for the next 7 days. Take it in a cycle starting from the 5th day of the next menstruation for a total of 2 cycles.
• Препарат High-dose estrogen
  1 day after abortion, give oral estradiol valerate, 2 mg Bid, for 21 days, and add dydrogesterone 10 mg Bid for the next 7 days. Take it in a cycle starting from the 5th day of the next menstruation for a total of 2 cycles.

Первичные конечные точки

• Number of Participants with Complete Abortion Following Treatment for Early Missed Abortion [Срок оценки: Within 14 days after initiation of treatment (medication or surgery)]
• Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment [Срок оценки: At 3 months after treatment (on the 16th-20th day of the third menstrual cycle post-treatment)]

Вторичные конечные точки (7)

• Time to Expulsion of Gestational Sac Following Medication Treatment [Срок оценки: From the first dose of misoprostol to expulsion, assessed up to 72 hours]
• Intraoperative Blood Loss During Surgical Treatment [Срок оценки: During the surgical procedure]
• Operative Time for Surgical Treatment [Срок оценки: During the surgical procedure]
• Number of Participants with Adverse Drug Reactions During Medication Treatment [Срок оценки: From the first dose of medication to 7 days after treatment completion]
• Change from Baseline in Menstrual Blood Volume at 3 Months Post-Treatment [Срок оценки: Baseline (self-reported usual menstrual volume before pregnancy) and at 3 months after treatment]
• Number of Participants with Residual Gestational Tissue at 14 Days Post-Treatment [Срок оценки: At 14 days after 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]

Критерии участия

Критерии включения

• ①Age 18-40 years old; ②Early pregnancy missed abortion confirmed by imaging and laboratory tests; ③All indicators of routine examinations before treatment are within the normal range, and there are no serious systemic diseases; ④No indications for emergency curettage; ⑤Good compliance, follow-up observation as required (prospective study).

Критерии исключения

• ①Contraindications to medical abortion; ②Those who are allergic to estrogen and have contraindications to the use of estrogen; ③Those who cannot be followed up according to the follow-up plan; ④Thromboembolic diseases, known or suspected history of breast cancer, hormone-dependent tumors, etc.; ⑤Vaginal bleeding exceeds the usual menstrual volume; ⑥Those with severe heart, liver and kidney diseases; ⑦Accompanied by serious internal and surgical diseases, malignant tumors or mental illnesses, and cannot cooperate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07422506 · xy3-EMA-Xu

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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