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CompletedNCT01481740Updated Apr 23, 2018Results posted

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

A Phase 4 interventional study of Phenylephrine bolus and phenylephrine infusion in Hypotension, sponsored by IWK Health Centre. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-23.

Sponsored by IWK Health Centre · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
178
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hypotension

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Keywords

  • spinal induced hypotension
  • nausea and vomiting
  • cesarean delivery
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 178 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

IWK Health Centre is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
178 participants (actual)

Study arms

  • Experimental
    Phenylephrine bolus

    Drug: Phenylephrine bolus

  • Experimental
    Phenylephrine infusion

    Drug: phenylephrine infusion

Interventions

  • DrugPhenylephrine bolus

    10 ml of 100mcg/ml phenylephrine and placebo infusion

  • Drugphenylephrine infusion

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

06

What researchers measure

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

07

Results

Posted Nov 2, 2016

Participant flow

Participant flow — Overall Study
MilestonePhenylephrine BolusPhenylephrine Infusion
Started9088
Completed7981
Not completed117

Outcome measures

PrimaryIncidence of Nausea and Vomiting
Time frame:
intraoperative 2-3 hours
Reported as:
Number · participants
Incidence of Nausea and Vomiting
participantsPhenylephrine BolusPhenylephrine Infusion
Incidence of Nausea and Vomiting5937
PrimaryIncidence of Nausea and Vomiting
Time frame:
2 hrs postoperative
Reported as:
Number · participants
Incidence of Nausea and Vomiting
participantsPhenylephrine BolusPhenylephrine Infusion
Incidence of Nausea and Vomiting2926
PrimaryIncidence of Nausea and Vomiting
Time frame:
24hrs postoperative
Reported as:
Number · participants
Incidence of Nausea and Vomiting
participantsPhenylephrine BolusPhenylephrine Infusion
Incidence of Nausea and Vomiting2628
SecondaryIncidence of Hypotension
Time frame:
intraoperative - predelivery
Reported as:
Number · participants
Incidence of Hypotension
participantsPhenylephrine BolusPhenylephrine Infusion
Incidence of Hypotension5922
SecondaryIncidence of Hypotension
Time frame:
intraoperative - postdelivery
Reported as:
Number · participants
Incidence of Hypotension
participantsPhenylephrine BolusPhenylephrine Infusion
Incidence of Hypotension346
SecondaryNeonatal Acidosis
Time frame:
intraoperative
Reported as:
Mean · pH value
Neonatal Acidosis
pH valuePhenylephrine BolusPhenylephrine Infusion
Neonatal Acidosis7.27 ± 0.067.27 ± 0.07

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phenylephrine Bolus—0/79 (0%)0/79 (0%)
Phenylephrine Infusion—0/81 (0%)0/81 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Phenylephrine BolusPhenylephrine InfusionTotal
Mean32 ± 631 ± 531 ± 5
Sex: Female, Male
Sex: Female, Male(Participants)Phenylephrine BolusPhenylephrine InfusionTotal
Female7981160
Male000
Region of Enrollment
Region of Enrollment(participants)Phenylephrine BolusPhenylephrine InfusionTotal
Canada5456110
United States252550
08

Study locations

2 sites
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • IWK Health Centre
    Halifax, Nova Scotia B3H 6K8, Canada
09

References and documents

Publications

  • George RB, McKeen DM, Dominguez JE, Allen TK, Doyle PA, Habib AS. A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women. Can J Anaesth. 2018 Mar;65(3):254-262. doi: 10.1007/s12630-017-1034-6. Epub 2017 Dec 5. PubMed 29209926 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01481740
Lead sponsor
IWK Health Centre
Collaborators
Duke University
Responsible party
Ronald George (Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre) — Principal investigator
First posted
Nov 30, 2011
Start date
Nov 2010
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Nov 2, 2016
Last update
Apr 23, 2018

Study contacts

Ronald B George, MD FRCPC
principal investigator · IWK Health Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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