Phenylephrine Versus Ephedrine in Pre-eclampsia

NCT02025426 | Terminated Phase 4 Results

• 1 other identifier: Pro00032812
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-eclampsia

Keywords

Cesarean delivery; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Cerebral Tissue Oxygen Saturation

  Intraoperative from spinal placement till 10 min after delivery

Secondary Outcomes (1)

• Cardiac Output

  Intraoperative from spinal placement till 10 min after delivery

Other Outcomes (6)

• Neonatal Umbilical Cord Gases, pCO2

  Within 5 minutes after delivery

• Neonatal Umbilical Cord Gases, pH

  Within 5 minutes after delivery

• Neonatal Umbilical Cord Gases, BE

  Within 5 minutes after delivery

Study Arms (2)

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine for maintaining blood pressure within 10 % of baseline

Drug: Phenylephrine

Ephedrine

ACTIVE COMPARATOR

Ephedrine for maintaining blood pressure within 10 % of baseline

Drug: Ephedrine

Interventions

Phenylephrine DRUG

Phenylephrine

Ephedrine DRUG

Ephedrine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking
• Age ≥18 yrs
• Pre-eclampsia (mild, or severe)
• Non-laboring women
• CD under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Phenylephrine; Ephedrine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propanolamines; Propanols; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Dr. Ashraf Habib
• Organization: Duke University, School of Medicine, Department of Anesthesiology

ashraf.habib@duke.edu

(919) 681-4544

Study Officials

• Ashraf S Habib, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: January 1, 2014
• Study Start: September 1, 2012
• Primary Completion: July 8, 2016
• Study Completion: July 8, 2016
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09

Locations

US (1)