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

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypotension

In brief

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.

Key facts

Study ID

NCT01481740

Run by

IWK Health Centre

People needed

178

Starts

2010-11-01

Expected to finish

2014-12-01

Last updated by the study team

2018-04-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• IWK Health Centre — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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