Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

March 22, 2018 updated by: Ronald George, IWK Health Centre

A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients

Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 6K8
        • IWK Health Centre
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • English speaking
  • ASA Physical Status I-II
  • Non-laboring women
  • Single gestations ≥ 36 weeks
  • Obese women (Body Mass Index 35 - 55 kg/m2)
  • Non-emergent CD under spinal anesthesia

Exclusion Criteria:

  • Height < 5'0"
  • Antiemetic drug use in the 24 hours prior to CD
  • Allergy to phenylephrine, or any other standardized medication
  • Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)
  • Chronic hypertension receiving antihypertensive treatment
  • Severe Cardiac disease in pregnancy with marked functional limitations
  • Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phenylephrine bolus
10 ml of 100mcg/ml phenylephrine and placebo infusion
Experimental: Phenylephrine infusion
60ml infusion of 100mcg/ml phenylephrine and placebo bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Nausea and Vomiting
Time Frame: intraoperative 2-3 hours
intraoperative 2-3 hours
Incidence of Nausea and Vomiting
Time Frame: 2 hrs postoperative
2 hrs postoperative
Incidence of Nausea and Vomiting
Time Frame: 24hrs postoperative
24hrs postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Hypotension
Time Frame: intraoperative - predelivery
intraoperative - predelivery
Incidence of Hypotension
Time Frame: intraoperative - postdelivery
intraoperative - postdelivery
Neonatal Acidosis
Time Frame: intraoperative
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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