Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

February 6, 2024 updated by: Chung Pui Wah Jacqueline, Chinese University of Hong Kong
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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • Union Hospital
        • Contact:
          • Jacqueline Pui Wah Chung, MBBS
    • Shatin
      • Hong Kong, Shatin, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Tin Chui Li, MBBS, PhD
        • Sub-Investigator:
          • Tracy Law, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with first trimester miscarriage

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete evacuation rate of the products of conception
Time Frame: 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
Three weeks from surgery to follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Three weeks from surgery to follow-up
To assess the complications in patients undergoing the USG-MVA procedure
Three weeks from surgery to follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2021

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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