Phenylephrine Versus Ephedrine in Pre-eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02025426
Recruitment Status : Recruiting
First Posted : January 1, 2014
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Pre-eclampsia Drug: Phenylephrine Drug: Ephedrine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : September 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cerebral tissue oxygen saturation [ Time Frame: Intraoperative from spinal placement till 10 min after delivery ]

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Duke University Identifier: NCT02025426     History of Changes
Other Study ID Numbers: Pro00032812
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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