Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound
1 other identifier
observational
57
1 country
2
Brief Summary
The objective of this study is to assess equivalency of the transabdominal Clarius handheld wifi C3 ultrasound (which uses Bluetooth to locate the ipad Mini 5 and then uses wifi direct to show the images) to the current standard of care in Women's Hospital outpatient department the portable Zonare ZS3 in patients presenting in the first trimester of pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Shorter than P25 for all trials
2 active sites
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
First Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
June 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2020
CompletedResults Posted
Study results publicly available
January 25, 2024
CompletedJanuary 25, 2024
May 1, 2023
7 months
May 13, 2019
May 17, 2021
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Can Both Transabdominal Ultrasounds See a Gestational Sac and Yolk Sac or Embryo?
Number of participants with both ultrasounds showing a gestational sac with a yolk sac or embryo
Results will be known immediately after both ultrasounds are completed
Secondary Outcomes (1)
Can Both Transabdominal Ultrasounds Give a Crown Rump Length or Gestational Sac Size to Within 5 Days
Results will be known immediately after both are completed
Eligibility Criteria
Patients are presenting for an ultrasound prior to first trimester termination of pregnancy.
You may qualify if:
- Presenting requesting medical or surgical abortion
- Estimated to be under 13 weeks gestational age based on last menstrual period or time of conception, or nurses best estimate.
- Able to provide informed consent with adult supervision of a minor or with an interpreter present
You may not qualify if:
- \. Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Womens Hospital- 735 Notre Dame Ave
Winnipeg, Manitoba, R3E 0L8, Canada
Women's Hospital 820 Sherbrook St (moved hospitals Dec 2019)
Winnipeg, Manitoba, R3H 1R9, Canada
Related Publications (1)
Van den Hof MC, Smithies M, Nevo O, Oullet A. No. 375-Clinical Practice Guideline on the Use of First Trimester Ultrasound. J Obstet Gynaecol Can. 2019 Mar;41(3):388-395. doi: 10.1016/j.jogc.2018.09.020.
PMID: 30784569BACKGROUND
Results Point of Contact
- Title
- Dr Helen Pymar
- Organization
- University of manitoba
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 21, 2019
Study Start
June 18, 2019
Primary Completion
January 4, 2020
Study Completion
April 5, 2020
Last Updated
January 25, 2024
Results First Posted
January 25, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share