Pregnancy EarlyNCT03957200
Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound
An observational study of Pregnancy Early, run by University of Manitoba at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Early
- How many people
- 57 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Jun 2019to 5 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients are presenting for an ultrasound prior to first trimester termination of pregnancy.
Who may be able to join
- 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
Who cannot join
- 1. Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Womens Hospital- 735 Notre Dame Ave
Winnipeg, Manitoba, R3E 0L8
Women's Hospital 820 Sherbrook St (moved hospitals Dec 2019)
Winnipeg, Manitoba, R3H 1R9
About this study
Official title: Assessing Gestational Age in First Trimester Pregnancies: A Comparison of a New Handheld Wireless Transabdominal Ultrasound to a Portable Transabdominal Ultrasound
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.
Read the detailed description
This is a prospective study in which first trimester participants who are presenting to discuss termination of pregnancy, will consent to have an additional transabdominal ultrasound with the Clarius C3 immediately prior to their standard ultrasound which is performed to date their pregnancy. Participants who are presenting for medical abortion have been prescreened to be estimated to be less than 9 weeks GA. Participants who are being seen prior to surgical abortion will have been screened by nurses based on their last menstrual period or estimated time of conception to estimate their gestational age. Potential participants estimated to be less than 13 weeks GA, will be approached to see if they are interested in participating in the study before they are seen by their health care provider. The name, date of approach, and reason for decline of potential participants who refuse to participate will be documented. If agreeable, the participant will complete consent with a study nurse or medical student for the additional ultrasound.
Participants will then receive the 2 ultrasounds by the same health care provider with the Clarius C3 ultrasound first, then the standard care ultrasound. Occasionally, there may be a different provider doing the Clarius C3 ultrasound when the patient consents.
Participants will receive standard care for medical or surgical abortion. The following information will be documented from their chart:
Height and weight, age, Obstetrical history (Gravida, para, number cesareans, ectopic pregnancies, spontaneous abortions, therapeutic abortions). If they do not have a documented intrauterine pregnancy, the standard questions to rule out possibility of ectopic pregnancy will be determined, and any positive answers will be documented in the chart. Anyone without a documented intrauterine pregnancy (no gestational sac or a gestational sac with no definite crown rump length or yolk sac) will be followed until a final outcome is determined or they are lost to follow up. When the patient has a pregnancy of unknown location (no evidence of a pregnancy inside or outside of the uterus), their data will not be used to compare the two ultrasounds but future outcome will be recorded.
The final outcome of their pregnancy and any complications will be determined within the next 6 weeks with the following potential outcomes:
completed medical abortion, completed surgical abortion (possibily following failed medical abortion), lost to follow up, continuing pregnancy, or ectopic pregnancy.
If a participant is determined to be over 13 weeks GA, they will receive a dating ultrasound with the Clarius C3 ultrasound using biparietal diameter as appropriate but it will not be included in the final study measurements.
- Conditions
- Pregnancy Early
- Keywords
- Ultrasound, pregnancy, first trimester, dating
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Number of participants with both ultrasounds showing a crown rump length or gestational sac measurement within 5 days of error.
Measured: Results will be known immediately after both are completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start18 Jun 2019
- Primary completion4 Jan 2020
- Study completion5 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy EarlyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Pymar, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957200
- Sponsor's protocol ID
- HS22818 (B2019:034)
- Status last verified
- May 2023
- First submitted
- 13 May 2019
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30784569
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Gestational Age in First Trimester Pregnancies: A Comparison of a New Handheld Wireless Transabdominal Ultrasound to a Portable Transabdominal Ultrasound
- ClinicalTrials.gov ID
- NCT03957200
- Acronym / sponsor ID
- HS22818 (B2019:034)
- Conditions
- Pregnancy Early
- Keywords
- Ultrasound, pregnancy, first trimester, dating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Posted 25 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective study in which first trimester participants who are presenting to discuss termination of pregnancy, will consent to have an additional transabdominal ultrasound with the Clarius C3 immediately prior to their standard ultrasound which is performed to date their pregnancy. Participants who are presenting for medical abortion have been prescreened to be estimated to be less than 9 weeks GA. Participants who are being seen prior to surgical abortion will have been screened by nurses based on their last menstrual period or estimated time of conception to estimate their gestational age. Potential participants estimated to be less than 13 weeks GA, will be approached to see if they are interested in participating in the study before they are seen by their health care provider. The name, date of approach, and reason for decline of potential participants who refuse to participate will be documented. If agreeable, the participant will complete consent with a study nurse or medical student for the additional ultrasound.
Participants will then receive the 2 ultrasounds by the same health care provider with the Clarius C3 ultrasound first, then the standard care ultrasound. Occasionally, there may be a different provider doing the Clarius C3 ultrasound when the patient consents.
Participants will receive standard care for medical or surgical abortion. The following information will be documented from their chart:
Height and weight, age, Obstetrical history (Gravida, para, number cesareans, ectopic pregnancies, spontaneous abortions, therapeutic abortions). If they do not have a documented intrauterine pregnancy, the standard questions to rule out possibility of ectopic pregnancy will be determined, and any positive answers will be documented in the chart. Anyone without a documented intrauterine pregnancy (no gestational sac or a gestational sac with no definite crown rump length or yolk sac) will be followed until a final outcome is determined or they are lost to follow up. When the patient has a pregnancy of unknown location (no evidence of a pregnancy inside or outside of the uterus), their data will not be used to compare the two ultrasounds but future outcome will be recorded.
The final outcome of their pregnancy and any complications will be determined within the next 6 weeks with the following potential outcomes:
completed medical abortion, completed surgical abortion (possibily following failed medical abortion), lost to follow up, continuing pregnancy, or ectopic pregnancy.
If a participant is determined to be over 13 weeks GA, they will receive a dating ultrasound with the Clarius C3 ultrasound using biparietal diameter as appropriate but it will not be included in the final study measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients are presenting for an ultrasound prior to first trimester termination of pregnancy.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can Both Transabdominal Ultrasounds See a Gestational Sac and Yolk Sac or Embryo?
Time frame: Results will be known immediately after both ultrasounds are completed
Number of participants with both ultrasounds showing a gestational sac with a yolk sac or embryo
1 secondary outcome
Can Both Transabdominal Ultrasounds Give a Crown Rump Length or Gestational Sac Size to Within 5 Days
Time frame: Results will be known immediately after both are completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30784569Van 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnancy Early, run by University of Manitoba at 2 sites in Canada.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jan 2024. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can Both Transabdominal Ultrasounds See a Gestational Sac and Yolk Sac or Embryo? (time frame: Results will be known immediately after both ultrasounds are completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957200, which also lists 1 linked publication.
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 25 Jan 2024.