Trial Outcomes & Findings for Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester (NCT NCT01201486)
NCT ID: NCT01201486
Last Updated: 2016-04-27
Results Overview
The number of \*fetuses with\* heart defects detected by color Doppler in the second trimester was compared to the number of \*fetuses with\* major heart defects detected at birth.
Recruitment status
COMPLETED
Target enrollment
6781 participants
Primary outcome timeframe
2nd trimester
Results posted on
2016-04-27
Participant Flow
Participant milestones
| Measure |
Pregnant Women in Second Trimester
Pregnant females in the 2nd trimester.
|
|---|---|
|
Overall Study
STARTED
|
6781
|
|
Overall Study
COMPLETED
|
6781
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester
Baseline characteristics by cohort
| Measure |
Pregnant Women in Second Trimester
n=6781 Participants
Pregnant females in the 2nd trimester.
|
|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6781 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2nd trimesterThe number of \*fetuses with\* heart defects detected by color Doppler in the second trimester was compared to the number of \*fetuses with\* major heart defects detected at birth.
Outcome measures
| Measure |
Pregnant Women
n=6781 Participants
Pregnant females in the 2nd trimester.
|
|---|---|
|
Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy
Major Heart Defects at Delivery
|
39 fetuses
|
|
Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy
Heart Defects Detected by Color Dopple
|
9 fetuses
|
Adverse Events
Pregnant Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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