Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

Обзор

This is a retrospective study to review the current experience of USG-MVA in Hong Kong and also evaluate the effectiveness of USG-MVA in cytological analysis in the management of first trimester miscarriage.

Подробное описание

Miscarriage can be managed expectantly, medically or surgically. In cases where cytogenetic analysis is wanted, surgical evacuation is the ideal option as the POC is difficult to be obtained after medical evacuation. However, traditional surgical evacuation requires the procedure to be performed under general anesthesia using an electric vacuum aspiration (EVA). Moreover, the chorionic villi obtained via POC is often less intact and dispersed, making the identification and analysis difficult. Manual vacuum aspiration (MVA) was first introduced in 1973. The procedure is performed using a hand-held 60ml syringe to create the suction force and the intrauterine contents are aspirated using either a flexible or rigid cannula attached on it. The procedure can be performed in an outpatient setting with simple oral analgesics or conscious sedation given beforehand.

The investigators have previously evaluated the acceptability and feasibility of the addition of ultrasound guidance during the procedure. The investigators found that ultrasound-guided manual vacuum aspiration (USG-MVA) is an effective alternative treatment modality to medical and traditional surgical evacuation under general anesthesia for the management of first trimester delayed or incomplete miscarriage. The procedure has been introduced in our locality since 2015. Since then, the investigators have performed more than 200 cases of USG-MVA locally. However, the subsequent local experience of USG-MVA and culture failure rate in the POC during cytological analysis obtained via this method remains limited in the literature.

Вмешательства

• Процедура ultrasound-guided manual vacuum aspiration (USG- MVA)
  USG-MVA was carried out as an outpatient day procedure. Women was given a 400μg oral misoprostol tablet 2-3 hours before the procedure. All patients will be given 500mg naproxen orally an hour before the procedure. During the USG-MVA, all the women were placed in the lithotomy position and aseptically dressed. Speculum was performed to visualize the cervix with PCB performed. USG-MVA was performed using a 60ml charged syringe with a flexible curetteattached to it. Transabdominal USG during MVA w

Первичные конечные точки

• complete evacuation rate of the products of conception [Срок оценки: Three weeks from surgery to follow-up]

Вторичные конечные точки (1)

• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Three weeks from surgery to follow-up]

Критерии участия

Критерии включения

• Women 18 years old or above
• Women with miscarriage who are suitable candidates for USG-MVA
• first trimester delayed miscarriage ≤ 12 weeks of gestation
• incomplete miscarriage with POG ≤ 5cm
• hemodynamically stable
• tolerates well with speculum examination

Критерии исключения

• Women who are not feasible for the USG-MVA
• cervical stenosis
• fibroid uterus ≥12 weeks in size
• known uterine malformation
• bleeding disorder
• suspicion of active infection
• inability to tolerate pelvic examination
• History of allergy to misprostol or same group of medications

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Гонконг · 2 центра

• Chinese University of Hong Kong — Гонконг
• Union Hospital — Гонконг

Идентификаторы

NCT: NCT05413525 · 2021.206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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