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NCT Number: NCT05413525

Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chinese University of Hong Kong, Hong Kong, Shatin

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline Pui Wah Chung

CONTACT

[email protected]

+852 3505 1537

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 10, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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