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Phenylephrine Versus Ephedrine in Pre-eclampsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02025426
First received: December 26, 2013
Last updated: March 23, 2017
Last verified: March 2017
  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: 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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: December 26, 2013
Last Updated: March 23, 2017

Keywords provided by Duke University:
Cesarean delivery
Spinal Anesthesia

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Ephedrine
Phenylephrine
Oxymetazoline
Pseudoephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Protective Agents

ClinicalTrials.gov processed this record on May 25, 2017