NCT05413525

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2021Jun 2026

Study Start

First participant enrolled

June 20, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

May 25, 2022

Last Update Submit

March 18, 2025

Conditions

Ultrasound-guided Manual Vacuum AspirationFirst Trimester Spontaneous Abortion

Keywords

USG-MVAUltrasound-guided manual vacuum aspirationMiscarriageCytological analysisManual vacuum aspiration

Outcome Measures

Primary Outcomes (1)

  • complete evacuation rate of the products of conception

    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 Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Three weeks from surgery to follow-up

Study Arms (1)

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)

Interventions

ultrasound-guided manual vacuum aspiration (USG- MVA)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.

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with first trimester miscarriage

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

RECRUITING

Union Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Jacqueline Pui Wah Chung

CONTACT

+852 3505 1537jacquelinechung@cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 10, 2022

Study Start

June 20, 2021

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

HK(2)