Status:
COMPLETED
Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)
Lead Sponsor:
IWK Health Centre
Collaborating Sponsors:
Duke University
Conditions:
Hypotension
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 nation...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01481740
Start Date
November 1 2010
End Date
December 1 2014
Last Update
April 23 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
IWK Health Centre
Halifax, Nova Scotia, Canada, B3H 6K8