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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by IWK Health Centre
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01481740
First received: July 22, 2011
Last updated: September 3, 2014
Last verified: September 2014

July 22, 2011
September 3, 2014
November 2010
December 2014   (final data collection date for primary outcome measure)
  • incidence of nausea and vomiting [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: 2 hrs postoperative ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: 24hrs postoperative ] [ Designated as safety issue: No ]
incidence of nausea and vomiting [ Time Frame: intraoperative, 2 hrs postoperative, 24hrs postoperative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01481740 on ClinicalTrials.gov Archive Site
  • incidence of hypotension [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • neonatal acidosis [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypotension
  • Drug: Phenylephrine bolus
    10 ml of 100mcg/ml phenylephrine and placebo infusion
  • Drug: phenylephrine infusion
    60ml infusion of 100mcg/ml phenylephrine and placebo bolus
  • Experimental: Phenylephrine bolus
    Intervention: Drug: Phenylephrine bolus
  • Experimental: Phenylephrine infusion
    Intervention: Drug: phenylephrine infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States,   Canada
 
NCT01481740
4999-01460
Yes
Ronald George, IWK Health Centre
IWK Health Centre
Duke University
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre
IWK Health Centre
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP