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NCT Number: NCT01481740

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IWK Health Centre, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine bolus

Drug

10 ml of 100mcg/ml phenylephrine and placebo infusion

Phenylephrine infusion

Drug

60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Primary outcomes

  1. Incidence of Nausea and Vomiting

    Time frame: intraoperative 2-3 hours

  2. Incidence of Nausea and Vomiting

    Time frame: 2 hrs postoperative

  3. Incidence of Nausea and Vomiting

    Time frame: 24hrs postoperative

Secondary outcomes

  1. Incidence of Hypotension

    Time frame: intraoperative - predelivery

  2. Incidence of Hypotension

    Time frame: intraoperative - postdelivery

  3. Neonatal Acidosis

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Duke University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2011
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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