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Набор скоро начнётся NCT07732231

Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage

Без фазы С лечением Miscarriage Pregnancy Loss First Trimester Pregnancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Manual vacuum aspiration (MVA), Electric aspiration (EA).
Кому может быть актуально
Состояния в реестре: Miscarriage, Pregnancy Loss, First Trimester Pregnancy. Базовые параметры: 18 лет — 44 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)

Обзор

The ASPIR study aims to evaluate the cost-utility of outpatient manual vacuum aspiration compared with operating room electric aspiration for the management of first-trimester miscarriage. It is hypothesized that manual aspiration will demonstrate equivalent clinical efficacy and patient quality of life while reducing healthcare costs.

Подробное описание

Miscarriage occurs in approximately 15% of pregnancies during the first trimester. In France, surgical management usually involves electric aspiration in the operating room under anesthesia, associated with hospital admission. Manual vacuum aspiration (MVA) is widely used in low-resource settings and for induced abortion, with demonstrated safety and patient satisfaction. This multicenter randomized controlled trial compares outpatient MVA under local anesthesia and inhaled analgesia versus electric aspiration (EA) under anesthesia in the operating room.

The primary objective is to assess the incremental cost-utility ratio (ICUR, cost per QALY) at 3 months. Secondary outcomes include complications, pain, satisfaction, quality of life, and fertility at 12 months. The study anticipates enrolling 860 participants across multiple centers in France.

Вмешательства

  • Процедура Manual vacuum aspiration (MVA)
    Performed in consultation under local anesthesia and inhaled analgesia, using a manual vacuum aspirator and appropriate cannula. Post-procedure pelvic ultrasound to confirm complete evacuation.
  • Процедура Electric aspiration (EA)
    Performed in the operating room under general or regional anesthesia, using an electric suction device and appropriate cannula. Post-procedure pelvic ultrasound to confirm complete evacuation.

Первичные конечные точки

  • Incremental cost-utility ratio (ICUR) [Срок оценки: 3 months]
Вторичные конечные точки (12)
  • Annual net financial benefit for health insurance over up to 5 years of different development scenarios for manual vacuum aspiration in consultation for the management of pregnancies terminated before 12 weeks of gestation [Срок оценки: up to 5 years]
  • To compare the two management strategies in terms of success and intraoperative and postoperative complications [Срок оценки: 1 month]
  • To assess patient satisfaction [Срок оценки: day 1 and 2]
  • To compare the two strategies (electric suction versus manual vacuum kit suction) [Срок оценки: days 0, 1,7 and 1 and 3 months]
  • The risk factors for failure [Срок оценки: 3 months]
  • Satisfaction with the patient's care by medical staff [Срок оценки: day 0 and 1 month]
  • Patient having been pregnant in days [Срок оценки: 12 months]
  • To assess patient satisfaction [Срок оценки: day 1 and 2 and 1 month et 3 month]
  • To assess patient satisfaction [Срок оценки: 1 and 3 months]
  • To compare the two strategies (electric suction versus manual vacuum kit suction) [Срок оценки: Day 0, 1,7 and 1 and 3 months]
  • To compare the two strategies (electric suction versus manual vacuum kit suction) [Срок оценки: Day 0 to 7]
  • To compare the two strategies (electric suction versus manual vacuum kit suction) [Срок оценки: Day 0 to 7]

Критерии участия

Критерии включения

  • Female, aged 18-44 years
  • Ultrasound-confirmed first-trimester miscarriage requiring surgical management
  • Gestational age between 5 and 12 weeks of amenorrhea
  • Incomplete spontaneous abortion or ongoing non-viable pregnancy
  • Patient able to provide oral informed consent

Критерии исключения

  • Complete expulsion of pregnancy (endometrial thickness < 15 mm)
  • Choice of medical treatment with misoprostol
  • Elective termination of pregnancy
  • Unwanted pregnancy
  • Pregnancy of unknown location, molar pregnancy
  • Known uterine malformation
  • Prior surgical aspiration for the current pregnancy
  • Intrauterine device in place
  • Contraindicating medications (e.g. anticoagulants)
  • Protected adults (under guardianship)
  • Inability to complete study questionnaires
  • Lack of social security coverage
  • Haemorrhagic miscarriage

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Франция · 1 центр
  • CHU de Nantes — Nantes

Идентификаторы

NCT: NCT07732231 · RC24_0471 · 2025-A00724-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗