NCT02245191

Brief Summary

It is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

May 1, 2014

Enrollment Period

Same day

First QC Date

August 7, 2014

Last Update Submit

September 16, 2014

Conditions

Preeclampsia

Keywords

VasopressorCesarian deliveryHypotensionMaternal cardiac outputUteroplacental blood flowCerebral fetal blood flowPreeclampsia

Outcome Measures

Primary Outcomes (4)

  • Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.

    The main purpose of this study is evaluate if one of related drugs (ephedrine, phenylephrine or metaraminol) is superior than others to keep the maternal cardiac output, uteroplacental and fetal cerebral bloodflow despite the hemodynamic changes that is peculiar after spinal anesthesia.

    One year

  • Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia

    One year

  • Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.

    One year

  • Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use

    One year

Study Arms (3)

Ephedrine Group

EXPERIMENTAL

Patients who will receive ephedrine after spinal anesthesia

Drug: Ephedrine

Phenylephrine Group

EXPERIMENTAL

Patients who will receive Phenylephrine after spinal anesthesia

Drug: Phenylephrine

Metaraminol

EXPERIMENTAL

Patients who will receive Metaraminol after spinal anesthesia

Drug: Metaraminol

Interventions

EphedrineDRUG

5mg after Spinal Anesthesia

Ephedrine Group
PhenylephrineDRUG

100mcg after Spinal Anesthesia

Phenylephrine Group
MetaraminolDRUG

200mcg Metaraminol after Spinal Anesthesia

Metaraminol

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preeclampsia patients
  • After 34 weeks pregnant

You may not qualify if:

  • Patients' refusal
  • Obstetric Emergency
  • Contraindications to spinal anesthesia
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pre-EclampsiaHypotension

Interventions

EphedrinePhenylephrineMetaraminol

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesEthanolaminesPhenylpropanolamine

Study Officials

  • Fernando Bliacheriene, MD

    Instituto do Coracao

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

September 19, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-05

Locations

BR(1)