This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Phenylephrine Versus Ephedrine in Pre-eclampsia

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Duke University
Information provided by (Responsible Party):
Duke University Identifier:
First received: December 26, 2013
Last updated: March 23, 2017
Last verified: March 2017
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
Pre-eclampsia Drug: Phenylephrine Drug: Ephedrine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Cardiac output [ Time Frame: Intraoperative from spinal placement till 10 min after delivery ]

Other Outcome Measures:
  • Neonatal umbilical cord gases [ Time Frame: Within 5 minutes after delivery ]
  • Intraoperative hypotension [ Time Frame: Intraoperatively from spinal placement till 10 minutes after delivery ]
  • Intraoperative nausea and vomiting [ Time Frame: Intraoperatively from time of spinal placement until end of surgery. ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (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   (Adult)
Sexes 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: March 23, 2017

Keywords provided by Duke University:
Cesarean delivery
Spinal Anesthesia

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Bronchodilator Agents
Anti-Asthmatic Agents processed this record on August 18, 2017