Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

Recruiting

• Conditions: First Trimester Spontaneous Abortion; Ultrasound-guided Manual Vacuum Aspiration
• Interventions: Procedure: ultrasound-guided manual vacuum aspiration (USG- MVA)

• Registration Number: NCT05413525
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-06-20
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing USG- MVA for the treatment of early pregnancy loss	ultrasound-guided manual vacuum aspiration (USG- MVA)	Medical notes of all women undergoing USG- MVA for the treatment of early pregnancy loss with gestation \< 12 weeks at the Department of Obstetrics and Gynaecology in The Prince of Wales Hospital and Union Hospital will be reviewed.

Primary Outcome Measures

Name	Time	Method
complete evacuation rate of the products of conception	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

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Three weeks from surgery to follow-up	To assess the complications in patients undergoing the USG-MVA procedure

Trial Locations

Locations (2)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Shatin, Hong Kong

Union Hospital; 🇭🇰 Hong Kong, Hong Kong