NCT01481740

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DRUG	Phenylephrine bolus	10 ml of 100mcg/ml phenylephrine and placebo infusion
DRUG	phenylephrine infusion	60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-11-30
• Last updated: 2018-04-23
• Results posted: 2016-11-02

Locations

2 sites across 2 countries: United States, Canada