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Phenylephrine Versus Ephedrine in Pre-eclampsia

Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02025426
Enrollment
13
Registered
2014-01-01
Start date
2012-09-30
Completion date
2016-07-08
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia

Keywords

Cesarean delivery, Spinal Anesthesia

Brief summary

Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.

Interventions

DRUGPhenylephrine
DRUGEphedrine

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* English speaking * Age ≥18 yrs * Pre-eclampsia (mild, or severe) * Non-laboring women * CD under spinal anesthesia

Exclusion criteria

* Height \< 5'0 * Allergy to phenylephrine or ephedrine, or any other standardized medication * Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV) * Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants * History of recent amphetamine or cocaine use. * Subject enrollment in another study involving a study medication within 30 days of CD * Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Design outcomes

Primary

MeasureTime frame
Cerebral Tissue Oxygen SaturationIntraoperative from spinal placement till 10 min after delivery

Secondary

MeasureTime frame
Cardiac OutputIntraoperative from spinal placement till 10 min after delivery

Other

MeasureTime frameDescription
Neonatal Umbilical Cord Gases, BEWithin 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.)
Number of Participants With Intraoperative HypotensionIntraoperatively from spinal placement till 10 minutes after delivery—
Neonatal Umbilical Cord Gases, pCO2Within 5 minutes after deliveryPartial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord.
Number of Participants With Intraoperative VomitingIntraoperatively from time of spinal placement until end of surgery—
Number of Participants With Intraoperative NauseaIntraoperatively from time of spinal placement until end of surgery—
Neonatal Umbilical Cord Gases, pHWithin 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Phenylephrine
Phenylephrine for maintaining blood pressure within 10 % of baseline Phenylephrine
9
Ephedrine
Ephedrine for maintaining blood pressure within 10 % of baseline Ephedrine
4
Total13

Baseline characteristics

CharacteristicPhenylephrineEphedrineTotal
Age, Continuous29.89 years
STANDARD_DEVIATION 8.72
39.25 years
STANDARD_DEVIATION 10.14
32.77 years
STANDARD_DEVIATION 9.83
BMI (Body Mass Index)40.53 kg/m^2
STANDARD_DEVIATION 11.58
44.55 kg/m^2
STANDARD_DEVIATION 12.85
41.77 kg/m^2
STANDARD_DEVIATION 11.59
Gestational Age32.67 weeks
STANDARD_DEVIATION 4.42
35.25 weeks
STANDARD_DEVIATION 3.59
33.46 weeks
STANDARD_DEVIATION 4.22
Gravida3.00 pregnancies
STANDARD_DEVIATION 1.85
3.25 pregnancies
STANDARD_DEVIATION 1.26
3.08 pregnancies
STANDARD_DEVIATION 1.62
Height163.22 cm
STANDARD_DEVIATION 4.94
163.47 cm
STANDARD_DEVIATION 6.47
163.30 cm
STANDARD_DEVIATION 5.17
Para1.25 births
STANDARD_DEVIATION 1.04
1.50 births
STANDARD_DEVIATION 1.29
1.33 births
STANDARD_DEVIATION 1.07
Race/Ethnicity, Customized
African American
6 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Caucasian
3 Participants2 Participants5 Participants
Region of Enrollment
United States
9 Participants4 Participants13 Participants
Sex: Female, Male
Female
9 Participants4 Participants13 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Weight107.76 kg
STANDARD_DEVIATION 29.62
117.35 kg
STANDARD_DEVIATION 27.26
110.71 kg
STANDARD_DEVIATION 28.14

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 4
other
Total, other adverse events
0 / 90 / 4
serious
Total, serious adverse events
0 / 90 / 4

Outcome results

Primary

Cerebral Tissue Oxygen Saturation

Time frame: Intraoperative from spinal placement till 10 min after delivery

ArmMeasureValue (MEAN)Dispersion
PhenylephrineCerebral Tissue Oxygen Saturation30.08 mmHgStandard Deviation 29.32
EphedrineCerebral Tissue Oxygen Saturation19.10 mmHgStandard Deviation 7.23
p-value: 0.547Kruskal-Wallis
Secondary

Cardiac Output

Time frame: Intraoperative from spinal placement till 10 min after delivery

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PhenylephrineCardiac Output8.19 mL/minuteStandard Deviation 4.76
Other Pre-specified

Neonatal Umbilical Cord Gases, BE

The 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.)

Time frame: Within 5 minutes after delivery

ArmMeasureValue (MEAN)Dispersion
PhenylephrineNeonatal Umbilical Cord Gases, BE-4.83 mmol/LStandard Deviation 2.47
EphedrineNeonatal Umbilical Cord Gases, BE-8.23 mmol/LStandard Deviation 6.71
p-value: 0.201Kruskal-Wallis
Other Pre-specified

Neonatal Umbilical Cord Gases, pCO2

Partial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord.

Time frame: Within 5 minutes after delivery

ArmMeasureValue (MEAN)Dispersion
PhenylephrineNeonatal Umbilical Cord Gases, pCO256.71 mmHgStandard Deviation 11.8
EphedrineNeonatal Umbilical Cord Gases, pCO255.93 mmHgStandard Deviation 12.97
p-value: 0.925Kruskal-Wallis
Other Pre-specified

Neonatal Umbilical Cord Gases, pH

Used to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions.

Time frame: Within 5 minutes after delivery

ArmMeasureValue (MEAN)Dispersion
PhenylephrineNeonatal Umbilical Cord Gases, pH7.24 unitlessStandard Deviation 0.07
EphedrineNeonatal Umbilical Cord Gases, pH7.19 unitlessStandard Deviation 0.15
p-value: 0.498Kruskal-Wallis
Other Pre-specified

Number of Participants With Intraoperative Hypotension

Time frame: Intraoperatively from spinal placement till 10 minutes after delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PhenylephrineNumber of Participants With Intraoperative Hypotension8 Participants
EphedrineNumber of Participants With Intraoperative Hypotension4 Participants
p-value: >0.999Fisher Exact
Other Pre-specified

Number of Participants With Intraoperative Nausea

Time frame: Intraoperatively from time of spinal placement until end of surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PhenylephrineNumber of Participants With Intraoperative Nausea5 Participants
EphedrineNumber of Participants With Intraoperative Nausea3 Participants
p-value: 0.962Fisher Exact
Other Pre-specified

Number of Participants With Intraoperative Vomiting

Time frame: Intraoperatively from time of spinal placement until end of surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PhenylephrineNumber of Participants With Intraoperative Vomiting2 Participants
EphedrineNumber of Participants With Intraoperative Vomiting1 Participants
p-value: >0.999Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026