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临床试验/NCT05413525
NCT05413525招募中不适用

Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
complete evacuation rate of the products of conception

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

complete evacuation rate of the products of conception

时间窗: Three weeks from surgery to follow-up

To evaluate the effectiveness in terms of the complete evacuation rate of the products of conception in patients undergoing USG-MVA in the treatment of first trimester miscarriage

次要结局

  • Incidence of Treatment-Emergent Adverse Events(Three weeks from surgery to follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chung Pui Wah Jacqueline

Associate Professor

Chinese University of Hong Kong

研究点 (2)

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