Phenylephrine Versus Ephedrine in Pre-eclampsia

NCT ID: NCT02025426

Last Updated: 2020-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-07-08

Brief Summary

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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

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Conditions

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Pre-eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phenylephrine

Phenylephrine for maintaining blood pressure within 10 % of baseline

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

Ephedrine

Ephedrine for maintaining blood pressure within 10 % of baseline

Group Type ACTIVE_COMPARATOR

Ephedrine

Intervention Type DRUG

Interventions

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Phenylephrine

Intervention Type DRUG

Ephedrine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashraf S Habib, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00032812

Identifier Type: -

Identifier Source: org_study_id

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