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Phenylephrine Versus Ephedrine in Pre-eclampsia

This study is currently recruiting participants.
Verified March 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02025426
First Posted: January 1, 2014
Last Update Posted: March 24, 2017
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.
Information provided by (Responsible Party):
Duke University
  Purpose
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

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02025426


Contacts
Contact: Ashraf S Habib, MD 919-668-6266 habib001@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Ashraf S Habib, MD    919-668-6266    habib001@mc.duke.edu   
Principal Investigator: Ashraf S Habib, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Ashraf S Habib, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02025426     History of Changes
Other Study ID Numbers: Pro00032812
First Submitted: December 26, 2013
First Posted: January 1, 2014
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by Duke University:
Cesarean delivery
Spinal Anesthesia

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Phenylephrine
Oxymetazoline
Ephedrine
Pseudoephedrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
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