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

Phase 4

Completed

• Conditions: Hypotension
• Interventions: Drug: phenylephrine infusion; Drug: Phenylephrine bolus

• Registration Number: NCT01481740
• Lead Sponsor: IWK Health Centre

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 Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-30
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-09-14
• Results First Submitted QC: 2016-09-14
• Results First Posted: 2016-11-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phenylephrine infusion	phenylephrine infusion	-
Phenylephrine bolus	Phenylephrine bolus	-

Primary Outcome Measures

Name	Time	Method
Incidence of Nausea and Vomiting	24hrs postoperative

Secondary Outcome Measures

Name	Time	Method
Incidence of Hypotension	intraoperative - postdelivery
Neonatal Acidosis	intraoperative

Trial Locations

Locations (2)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States