Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05413525
Collaborator
(none)
200
2
17.4
100
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultrasound-guided manual vacuum aspiration (USG- MVA)

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
Actual Study Start Date :
Jun 20, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Incidence of Treatment-Emergent Adverse Events [Three weeks from surgery to follow-up]

    To assess the complications in patients undergoing the USG-MVA procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese University of Hong Kong Hong Kong Shatin Hong Kong
2 Union Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05413525
Other Study ID Numbers:
  • 2021.206
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022