Back to resultsPhenylephrine Versus Ephedrine in Pre-eclampsia
Primary Purpose
Pre-eclampsia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phenylephrine
Ephedrine
Sponsored by
About this trial
This is an interventional treatment trial for Pre-eclampsia focused on measuring Cesarean delivery, Spinal Anesthesia
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Phenylephrine
Ephedrine
Arm Description
Phenylephrine for maintaining blood pressure within 10 % of baseline
Ephedrine for maintaining blood pressure within 10 % of baseline
Outcomes
Primary Outcome Measures
Cerebral Tissue Oxygen Saturation
Secondary Outcome Measures
Cardiac Output
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02025426
Brief Title
Phenylephrine Versus Ephedrine in Pre-eclampsia
Official Title
Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Significant challenges recruiting a difficult patient population with most surgeries occurring out of hours
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 8, 2016 (Actual)
Study Completion Date
July 8, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia
Keywords
Cesarean delivery, Spinal Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phenylephrine
Arm Type
Active Comparator
Arm Description
Phenylephrine for maintaining blood pressure within 10 % of baseline
Arm Title
Ephedrine
Arm Type
Active Comparator
Arm Description
Ephedrine for maintaining blood pressure within 10 % of baseline
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Primary Outcome Measure Information:
Title
Cerebral Tissue Oxygen Saturation
Time Frame
Intraoperative from spinal placement till 10 min after delivery
Secondary Outcome Measure Information:
Title
Cardiac Output
Time Frame
Intraoperative from spinal placement till 10 min after delivery
Other Pre-specified Outcome Measures:
Title
Neonatal Umbilical Cord Gases, pCO2
Description
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
Title
Neonatal Umbilical Cord Gases, pH
Description
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
Title
Neonatal Umbilical Cord Gases, BE
Description
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
Title
Number of Participants With Intraoperative Hypotension
Time Frame
Intraoperatively from spinal placement till 10 minutes after delivery
Title
Number of Participants With Intraoperative Nausea
Time Frame
Intraoperatively from time of spinal placement until end of surgery
Title
Number of Participants With Intraoperative Vomiting
Time Frame
Intraoperatively from time of spinal placement until end of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf S Habib, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Phenylephrine Versus Ephedrine in Pre-eclampsia
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