Trial Outcomes & Findings for Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia (NCT NCT02357264)
NCT ID: NCT02357264
Last Updated: 2017-05-15
Results Overview
Detection of Fluid in the lungs in patients with pre-eclampsia vs. pregnant patients without pre-eclampsia
Recruitment status
COMPLETED
Target enrollment
186 participants
Primary outcome timeframe
24-36 weeks
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Pre-eclampsia
Ultrasound of Pregnant Females 18+ with pre-Eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung
|
No Pre-eclampsia.
Ultrasound of Pregnant Females 18+ with no pre-eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
130
|
|
Overall Study
COMPLETED
|
56
|
130
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia
Baseline characteristics by cohort
| Measure |
Pre-eclampsia
n=56 Participants
Ultrasound of Pregnant Females 18+ with pre-Eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung
|
No Pre-eclampsia.
n=130 Participants
Ultrasound of Pregnant Females 18+ with no pre-eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 5.93 • n=5 Participants
|
31.1 years
STANDARD_DEVIATION 5.90 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 5.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
130 participants
n=7 Participants
|
186 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24-36 weeksDetection of Fluid in the lungs in patients with pre-eclampsia vs. pregnant patients without pre-eclampsia
Outcome measures
| Measure |
Pregnant Females Without Pre-Eclampsia
n=130 Participants
Pregnant Females who the OB/GYN physician suspects do not have pre-eclampsia
|
Pregnant Females With Suspicion of Pre-eclampsia
n=56 Participants
Pregnant females who the OB/GYN physician has suspicion that may have pre-eclampsia
|
|---|---|---|
|
Detection of Fluid in the Lungs
|
2 Participants
|
3 Participants
|
Adverse Events
Pre-eclampsia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Pre-eclampsia.
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