Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

NCT ID: NCT05413525

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-20
• Study Completion Date: 2026-06-30

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.

Conditions

Ultrasound-guided Manual Vacuum Aspiration; First Trimester Spontaneous Abortion

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Women undergoing USG- MVA for the treatment of early pregnancy loss

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.

ultrasound-guided manual vacuum aspiration (USG- MVA)

Intervention Type: PROCEDURE

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 was performed. During the procedure, local lidocaine gelwas applied to the cervical canal and over the end of the MVA catheter tip during the insertion.The USG-MVA was stopped as soon as USG confirmed that the uterine cavity was empty, defined as a thin endometrial lining with no evidence of retained products of conception.

Interventions

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 was performed. During the procedure, local lidocaine gelwas applied to the cervical canal and over the end of the MVA catheter tip during the insertion.The USG-MVA was stopped as soon as USG confirmed that the uterine cavity was empty, defined as a thin endometrial lining with no evidence of retained products of conception.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Chung Pui Wah Jacqueline

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

Site Status: RECRUITING

Union Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jacqueline Pui Wah Chung

Role: CONTACT

jacquelinechung@cuhk.edu.hk

+852 3505 1537

Facility Contacts

Margaret Lee

Role: primary

margaretlee@cuhk.edu.hk

35053199

Pui Wah Chung

Role: backup

jacquelinechung@cuhk.edu.hk

35053199

Jacqueline Pui Wah Chung, MBBS

Role: primary

Other Identifiers

2021.206

Identifier Type: -

Identifier Source: org_study_id