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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025426
Recruitment Status : Terminated (Significant challenges recruiting a difficult patient population with most surgeries occurring out of hours)
First Posted : January 1, 2014
Last Update Posted : January 10, 2020
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 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
Actual Primary Completion Date : July 8, 2016
Actual Study Completion Date : July 8, 2016


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. ]


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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

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


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ashraf S Habib, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02025426    
Other Study ID Numbers: Pro00032812
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Keywords provided by Duke University:
Cesarean delivery
Spinal Anesthesia
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Phenylephrine
Oxymetazoline
Ephedrine
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