Ultrasound-guided Manual Vacuum AspirationNCT05413525
Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
An observational study of Ultrasound-guided Manual Vacuum Aspiration and First Trimester Spontaneous Abortion, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ultrasound-guided Manual Vacuum Aspiration, First Trimester Spontaneous Abortion
- What is being tested?
- ultrasound-guided manual vacuum aspiration (USG- MVA)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesHong Kong
- Study dates
- 20 Jun 2021to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with first trimester miscarriage
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong, Shatin
Margaret Lee, 35053199, margaretlee@cuhk.edu.hk
Pui Wah Chung, 35053199, jacquelinechung@cuhk.edu.hk
- Recruiting
Union Hospital
Hong Kong
Jacqueline Pui Wah Chung, MBBS
About this study
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.
Read the 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.
- Being tested
- ultrasound-guided manual vacuum aspiration (USG- MVA)
- Keywords
- USG-MVA, Ultrasound-guided manual vacuum aspiration, Miscarriage, Cytological analysis, Manual vacuum aspiration
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided manual vacuum aspiration (USG- MVA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ultrasound-guided manual vacuum aspiration (USG- MVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three weeks from surgery to follow-up
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
To assess the complications in patients undergoing the USG-MVA procedure
Measured: Three weeks from surgery to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start20 Jun 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound-guided Manual Vacuum AspirationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413525
- Sponsor's protocol ID
- 2021.206
- Status last verified
- Mar 2025
- First submitted
- 25 May 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
- ClinicalTrials.gov ID
- NCT05413525
- Acronym / sponsor ID
- 2021.206
- Keywords
- USG-MVA, Ultrasound-guided manual vacuum aspiration, Miscarriage, Cytological analysis, Manual vacuum aspiration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing USG- MVA for the treatment of early pregnancy loss | – | Procedure: ultrasound-guided manual vacuum aspiration (USG- MVA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with first trimester miscarriage
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Women who are not feasible for the USG-MVA
- cervical stenosis
- fibroid uterus ≥12 weeks in size
- known uterine malformation
- bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Women undergoing USG- MVA for the treatment of early pregnancy loss |
Primary outcome
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
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Three weeks from surgery to follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound-guided Manual Vacuum Aspiration and First Trimester Spontaneous Abortion, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Pui Wah Chung (+852 3505 1537, jacquelinechung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete evacuation rate of the products of conception (time frame: Three weeks from surgery to follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.