Trial Outcomes & Findings for Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound (NCT NCT03957200)
NCT ID: NCT03957200
Last Updated: 2024-01-25
Results Overview
Number of participants with both ultrasounds showing a gestational sac with a yolk sac or embryo
COMPLETED
57 participants
Results will be known immediately after both ultrasounds are completed
2024-01-25
Participant Flow
75 patients were approached and 57 were eligible and provided consent.
Participant milestones
| Measure |
Patients Received Ultrasound With Clarius Followed by Ultrasound With Zonare
Transabdominal ultrasound performed with Clarius handheld ultrasound followed by portable ultrasound Zonare ZS3
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only included those with no pregnancy of unknown location or gestational age under 13 weeks GA
Baseline characteristics by cohort
| Measure |
Patients Received Ultrasound With Clarius Followed by Ultrasound With Zonare
n=57 Participants
Transabdominal ultrasound performed with Clarius handheld ultrasound followed by portable ultrasound Zonare ZS3
|
|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 6.6 • n=51 Participants • Only included those with no pregnancy of unknown location or gestational age under 13 weeks GA
|
|
Sex: Female, Male
Female
|
57 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=57 Participants
|
PRIMARY outcome
Timeframe: Results will be known immediately after both ultrasounds are completedNumber of participants with both ultrasounds showing a gestational sac with a yolk sac or embryo
Outcome measures
| Measure |
Both Definite IUP, Both SAC Seen, Zonare Saw Definite IUP Where Clarius Saw Sac
n=51 Participants
Women under 13 weeks of gestational age.
|
|---|---|
|
Can Both Transabdominal Ultrasounds See a Gestational Sac and Yolk Sac or Embryo?
|
51 Participants
|
SECONDARY outcome
Timeframe: Results will be known immediately after both are completedNumber of participants with both ultrasounds showing a crown rump length or gestational sac measurement within 5 days of error.
Outcome measures
Outcome data not reported
Adverse Events
Patients Received Ultrasound With Clarius Followed by Ultrasound With Zonare
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place