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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: IWK Health Centre

Current Primary Outcome:

  • Incidence of Nausea and Vomiting [ Time Frame: intraoperative ]
  • Incidence of Nausea and Vomiting [ Time Frame: 2 hrs postoperative ]
  • Incidence of Nausea and Vomiting [ Time Frame: 24hrs postoperative ]


Original Primary Outcome: Incidence of Nausea and Vomiting [ Time Frame: intraoperative, 2 hrs postoperative, 24hrs postoperative ]

Current Secondary Outcome:

  • Incidence of Hypotension [ Time Frame: intraoperative - predelivery ]
  • Incidence of Hypotension [ Time Frame: intraoperative - postdelivery ]
  • Neonatal Acidosis [ Time Frame: intraoperative ]


Original Secondary Outcome:

  • Incidence of Hypotension [ Time Frame: intraoperative ]
  • Neonatal Acidosis [ Time Frame: intraoperative ]


Information By: IWK Health Centre

Dates:
Date Received: July 22, 2011
Date Started: November 2010
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016