Trial Outcomes & Findings for Phenylephrine Versus Ephedrine in Pre-eclampsia (NCT NCT02025426)
NCT ID: NCT02025426
Last Updated: 2020-10-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
Intraoperative from spinal placement till 10 min after delivery
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
Phenylephrine
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
|
Overall Study
COMPLETED
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phenylephrine Versus Ephedrine in Pre-eclampsia
Baseline characteristics by cohort
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.89 years
STANDARD_DEVIATION 8.72 • n=93 Participants
|
39.25 years
STANDARD_DEVIATION 10.14 • n=4 Participants
|
32.77 years
STANDARD_DEVIATION 9.83 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Weight
|
107.76 kg
STANDARD_DEVIATION 29.62 • n=93 Participants
|
117.35 kg
STANDARD_DEVIATION 27.26 • n=4 Participants
|
110.71 kg
STANDARD_DEVIATION 28.14 • n=27 Participants
|
|
BMI (Body Mass Index)
|
40.53 kg/m^2
STANDARD_DEVIATION 11.58 • n=93 Participants
|
44.55 kg/m^2
STANDARD_DEVIATION 12.85 • n=4 Participants
|
41.77 kg/m^2
STANDARD_DEVIATION 11.59 • n=27 Participants
|
|
Height
|
163.22 cm
STANDARD_DEVIATION 4.94 • n=93 Participants
|
163.47 cm
STANDARD_DEVIATION 6.47 • n=4 Participants
|
163.30 cm
STANDARD_DEVIATION 5.17 • n=27 Participants
|
|
Gestational Age
|
32.67 weeks
STANDARD_DEVIATION 4.42 • n=93 Participants
|
35.25 weeks
STANDARD_DEVIATION 3.59 • n=4 Participants
|
33.46 weeks
STANDARD_DEVIATION 4.22 • n=27 Participants
|
|
Gravida
|
3.00 pregnancies
STANDARD_DEVIATION 1.85 • n=93 Participants
|
3.25 pregnancies
STANDARD_DEVIATION 1.26 • n=4 Participants
|
3.08 pregnancies
STANDARD_DEVIATION 1.62 • n=27 Participants
|
|
Para
|
1.25 births
STANDARD_DEVIATION 1.04 • n=93 Participants
|
1.50 births
STANDARD_DEVIATION 1.29 • n=4 Participants
|
1.33 births
STANDARD_DEVIATION 1.07 • n=27 Participants
|
PRIMARY outcome
Timeframe: Intraoperative from spinal placement till 10 min after deliveryOutcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Cerebral Tissue Oxygen Saturation
|
30.08 mmHg
Standard Deviation 29.32
|
19.10 mmHg
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: Intraoperative from spinal placement till 10 min after deliveryPopulation: Data for cardiac output from Physioflow worksheets was not available for two participants in the Phenylephrine group and all four participants in the Ephedrine group.
Outcome measures
| Measure |
Phenylephrine
n=7 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Cardiac Output
|
8.19 mL/minute
Standard Deviation 4.76
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 5 minutes after deliveryPartial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord.
Outcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Neonatal Umbilical Cord Gases, pCO2
|
56.71 mmHg
Standard Deviation 11.80
|
55.93 mmHg
Standard Deviation 12.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 5 minutes after deliveryUsed to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions.
Outcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Neonatal Umbilical Cord Gases, pH
|
7.24 unitless
Standard Deviation 0.07
|
7.19 unitless
Standard Deviation 0.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 5 minutes after deliveryThe amount of strong acid (in mmol/L) that needs to be added in vitro to 1 liter of fully oxygenated blood in order to return the sample to standard (normal) conditions (pH 7.40, pCO2 40 mmHg and temperature 37 °C.)
Outcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Neonatal Umbilical Cord Gases, BE
|
-4.83 mmol/L
Standard Deviation 2.47
|
-8.23 mmol/L
Standard Deviation 6.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperatively from spinal placement till 10 minutes after deliveryOutcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Number of Participants With Intraoperative Hypotension
|
8 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperatively from time of spinal placement until end of surgeryOutcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Number of Participants With Intraoperative Nausea
|
5 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperatively from time of spinal placement until end of surgeryOutcome measures
| Measure |
Phenylephrine
n=9 Participants
Phenylephrine for maintaining blood pressure within 10 % of baseline
Phenylephrine
|
Ephedrine
n=4 Participants
Ephedrine for maintaining blood pressure within 10 % of baseline
Ephedrine
|
|---|---|---|
|
Number of Participants With Intraoperative Vomiting
|
2 Participants
|
1 Participants
|
Adverse Events
Phenylephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ephedrine
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
Dr. Ashraf Habib
Duke University, School of Medicine, Department of Anesthesiology
Phone: (919) 681-4544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place