- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413525
Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jacqueline Pui Wah Chung
- Phone Number: +852 3505 1537
- Email: jacquelinechung@cuhk.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Union Hospital
-
Contact:
- Jacqueline Pui Wah Chung, MBBS
-
-
Shatin
-
Hong Kong, Shatin, Hong Kong
- Recruiting
- Chinese University of Hong Kong
-
Contact:
- Margaret Lee
- Phone Number: 35053199
- Email: margaretlee@cuhk.edu.hk
-
Contact:
- Pui Wah Chung
- Phone Number: 35053199
- Email: jacquelinechung@cuhk.edu.hk
-
Sub-Investigator:
- Tin Chui Li, MBBS, PhD
-
Sub-Investigator:
- Tracy Law, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Three weeks from surgery to follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Three weeks from surgery to follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.206
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ultrasound-guided Manual Vacuum Aspiration
-
Seoul National University HospitalCompletedEndobronchial Ultrasound Guided Transbronchial Needle AspirationKorea, Republic of
-
Tanta UniversityUnknownConventional Caudal Block | Ultrasound Guided Caudal Block | Ultrasound Guided Erector Spinae Block | Pediatric Hip SurgeryEgypt
-
KK Women's and Children's HospitalRecruitingUltrasound-guided Neuraxial ProceduresSingapore
-
Kasr El Aini HospitalCairo UniversityCompletedUltrasound Guided | Hand SurgeryEgypt
-
Istanbul UniversityCompletedShoulder Arthroplasty | Ultrasound GuidedTurkey
-
Seoul National University HospitalCompletedUltrasound Guided Central Venous CannulationKorea, Republic of
-
Cairo UniversityAbdelhamid, Bassant Mohamed, M.D.; Mohamed, Ahmed A., M.D.; Hala Mostafa Gomaa; Mohamed saeid AliCompletedUltrasound Guided L1,L2 Paravertebral BlockEgypt
-
University of IowaCompletedEfficacy of Ultrasound Guided Nerve Block
-
Tanta UniversityNot yet recruitingAnalgesia | Ultrasound Guided Block | Pediatric Surgery
-
University of New MexicoTerminatedIn-plane Ultrasound-guided Regional Anesthesia PerformanceUnited States
Clinical Trials on ultrasound-guided manual vacuum aspiration (USG- MVA)
-
Washington University School of MedicineCompletedAbortion in First TrimesterUnited States
-
Cairo UniversityAhmed Elgazzar HospitalCompleted
-
Ohio State University Comprehensive Cancer CenterRecruiting
-
Ottawa Hospital Research InstituteTerminated
-
Gynuity Health ProjectsCompletedIncomplete AbortionNigeria
-
Mayo ClinicNational Cancer Institute (NCI)Recruiting
-
Lawson Health Research InstituteAcademic Medical Organization of Southwestern OntarioRecruitingNon-Small Cell Lung CancerCanada
-
College of Medical Sciences Teaching Hospital....UnknownZygomatic Arch Fracture
-
Chinese University of Hong KongRecruitingGenetic Anticipation | Immunological AbnormalitiesHong Kong