Phenylephrine Versus Ephedrine in Pre-eclampsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Duke University
Information provided by (Responsible Party):
Duke University Identifier:
First received: December 26, 2013
Last updated: December 16, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Drug: Phenylephrine
Drug: Ephedrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cerebral tissue oxygen saturation [ Time Frame: Intraoperative from spinal placement till 10 min after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac output [ Time Frame: Intraoperative from spinal placement till 10 min after delivery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Neonatal umbilical cord gases [ Time Frame: Within 5 minutes after delivery ] [ Designated as safety issue: No ]
  • Intraoperative hypotension [ Time Frame: Intraoperatively from spinal placement till 10 minutes after delivery ] [ Designated as safety issue: No ]
  • Intraoperative nausea and vomiting [ Time Frame: Intraoperatively from time of spinal placement until end of surgery. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phenylephrine
Phenylephrine for maintaining blood pressure within 10 % of baseline
Drug: Phenylephrine
Active Comparator: Ephedrine
Ephedrine for maintaining blood pressure within 10 % of baseline
Drug: Ephedrine


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02025426

Contact: Ashraf S Habib, MD 919-668-6266

United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Ashraf S Habib, MD    919-668-6266   
Principal Investigator: Ashraf S Habib, MD         
Sponsors and Collaborators
Duke University
Principal Investigator: Ashraf S Habib, MD Duke University
  More Information

Responsible Party: Duke University Identifier: NCT02025426     History of Changes
Other Study ID Numbers: Pro00032812 
Study First Received: December 26, 2013
Last Updated: December 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Cesarean delivery
Spinal Anesthesia

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses processed this record on April 27, 2016