Phenylephrine Versus Ephedrine in Pre-eclampsia

Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia

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.

Study Overview

• Status: Terminated
• Conditions: Pre-eclampsia
• Intervention / Treatment: Drug: Phenylephrine; Drug: Ephedrine

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cerebral Tissue Oxygen Saturation	Intraoperative from spinal placement till 10 min after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac Output	Intraoperative from spinal placement till 10 min after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Umbilical Cord Gases, pCO2	Partial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord.	Within 5 minutes after delivery
Neonatal Umbilical Cord Gases, pH	Used to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions.	Within 5 minutes after delivery
Neonatal Umbilical Cord Gases, BE	The amount of strong acid (in mmol/L) that needs to be added in vitro to 1 liter of fully oxygenated blood in order to return the sample to standard (normal) conditions (pH 7.40, pCO2 40 mmHg and temperature 37 °C.)	Within 5 minutes after delivery
Number of Participants With Intraoperative Hypotension		Intraoperatively from spinal placement till 10 minutes after delivery
Number of Participants With Intraoperative Nausea		Intraoperatively from time of spinal placement until end of surgery
Number of Participants With Intraoperative Vomiting		Intraoperatively from time of spinal placement until end of surgery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashraf S Habib, MD, Duke University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 8, 2016
• Study Completion (Actual): July 8, 2016

Study Registration Dates

• First Submitted: December 26, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (Estimate): January 1, 2014

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cesarean delivery; Spinal Anesthesia
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Ephedrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: Pro00032812