Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

First Trimester Spontaneous Abortion Clinical Trial

Official title:

Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413525
• Other study ID #: 2021.206
• Status: Recruiting
• Start date: June 20, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Jacqueline Pui Wah Chung
• Phone: +852 3505 1537
• Email: jacquelinechung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• First Trimester Spontaneous Abortion

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong	Shatin
Hong Kong	Union Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment-Emergent Adverse Events	To assess the complications in patients undergoing the USG-MVA procedure	Three weeks from surgery to follow-up