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

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ClinicalTrials.gov Identifier: NCT01481740
Recruitment Status : Completed
First Posted : November 30, 2011
Results First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Phenylephrine bolus Drug: phenylephrine infusion Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
Study Start Date : November 2010
Primary Completion Date : December 2014
Study Completion Date : December 2014


Arms and Interventions

Arm Intervention/treatment
Experimental: Phenylephrine bolus Drug: Phenylephrine bolus
10 ml of 100mcg/ml phenylephrine and placebo infusion
Experimental: Phenylephrine infusion Drug: phenylephrine infusion
60ml infusion of 100mcg/ml phenylephrine and placebo bolus


Outcome Measures

Primary Outcome Measures :
  1. Incidence of Nausea and Vomiting [ Time Frame: intraoperative ]
  2. Incidence of Nausea and Vomiting [ Time Frame: 2 hrs postoperative ]
  3. Incidence of Nausea and Vomiting [ Time Frame: 24hrs postoperative ]

Secondary Outcome Measures :
  1. Incidence of Hypotension [ Time Frame: intraoperative - predelivery ]
  2. Incidence of Hypotension [ Time Frame: intraoperative - postdelivery ]
  3. Neonatal Acidosis [ Time Frame: intraoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481740


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3H 6K8
Sponsors and Collaborators
IWK Health Centre
Duke University
Investigators
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre
More Information

Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01481740     History of Changes
Other Study ID Numbers: 4999-01460
First Posted: November 30, 2011    Key Record Dates
Results First Posted: November 2, 2016
Last Update Posted: November 2, 2016
Last Verified: September 2016

Keywords provided by Ronald George, IWK Health Centre:
spinal induced hypotension
nausea and vomiting
cesarean delivery

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents