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Phenylephrine Versus Ephedrine in Pre-eclampsia

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pre-eclampsia

Intervention: Phenylephrine (Drug); Ephedrine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Ashraf S Habib, MD, Principal Investigator, Affiliation: Duke University

Overall contact:
Ashraf S Habib, MD, Phone: 919-668-6266, Email: habib001@mc.duke.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cerebral tissue oxygen saturation

Secondary outcome: Cardiac output

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

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

Duke University Medical Center, Durham, North Carolina 27705, United States; Recruiting
Ashraf S Habib, MD, Phone: 919-668-6266, Email: habib001@mc.duke.edu
Ashraf S Habib, MD, Principal Investigator
Additional Information

Starting date: September 2012
Last updated: March 4, 2015

Page last updated: August 23, 2015

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