Phenylephrine Versus Ephedrine in Pre-eclampsia

Phase 4

Terminated

• Conditions: Pre-eclampsia
• Interventions: Drug: Ephedrine; Drug: Phenylephrine

• Registration Number: NCT02025426
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Primary Completion: 2016-07-08
• Study Completion: 2016-07-08
• Disposition First Submitted: 2020-01-07
• Disposition First Submitted QC: 2020-01-07
• Disposition First Posted: 2020-01-10
• Status Verified: 2020-09
• Results First Submitted: 2020-09-18
• Results First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Results First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine	Ephedrine	Ephedrine for maintaining blood pressure within 10 % of baseline
Phenylephrine	Phenylephrine	Phenylephrine for maintaining blood pressure within 10 % of baseline

Primary Outcome Measures

Name	Time	Method
Cerebral Tissue Oxygen Saturation	Intraoperative from spinal placement till 10 min after delivery

Secondary Outcome Measures

Name	Time	Method
Cardiac Output	Intraoperative from spinal placement till 10 min after delivery

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States