HypotensionPhase 4NCT01481740
Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)
A Phase 4 study testing Phenylephrine bolus and phenylephrine infusion in people with Hypotension, run by IWK Health Centre at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- Phenylephrine bolus and phenylephrine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2010to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
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.
- Conditions
- Hypotension
- Being tested
- Phenylephrine bolus, phenylephrine infusion
- Keywords
- spinal induced hypotension, nausea and vomiting, cesarean delivery
- Medical subject headings
- Hypotension, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine bolusDrug
10 ml of 100mcg/ml phenylephrine and placebo infusion
phenylephrine infusionDrug
60ml infusion of 100mcg/ml phenylephrine and placebo bolus
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine bolus | Experimental | Not described Receives: Drug: Phenylephrine bolus |
| Phenylephrine infusion | Experimental | Not described Receives: Drug: phenylephrine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nausea and Vomiting
Measured: intraoperative 2-3 hours
Incidence of Nausea and Vomiting
Measured: 2 hrs postoperative
Incidence of Nausea and Vomiting
Measured: 24hrs postoperative
Secondary outcomes (3)
Incidence of Hypotension
Measured: intraoperative - predelivery
Incidence of Hypotension
Measured: intraoperative - postdelivery
Neonatal Acidosis
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Ronald George, IWK Health Centre
- Investigators
- Ronald B George, MD FRCPC, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481740
- Sponsor's protocol ID
- 4999-01460
- Status last verified
- Mar 2018
- First submitted
- 22 Jul 2011
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
- ClinicalTrials.gov ID
- NCT01481740
- Acronym / sponsor ID
- 4999-01460
- Conditions
- Hypotension
- Keywords
- spinal induced hypotension, nausea and vomiting, cesarean delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 2 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine bolus | Experimental | Drug: Phenylephrine bolus |
| Phenylephrine infusion | Experimental | Drug: phenylephrine infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaking
- ASA Physical Status I-II
- Non-laboring women
- Single gestations ≥ 36 weeks
- Obese women (Body Mass Index 35 - 55 kg/m2)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine bolus10 ml of 100mcg/ml phenylephrine and placebo infusion | Drug | Phenylephrine bolus |
| phenylephrine infusion60ml infusion of 100mcg/ml phenylephrine and placebo bolus | Drug | Phenylephrine infusion |
Primary outcome
Incidence of Nausea and Vomiting
Time frame: intraoperative 2-3 hours
Incidence of Nausea and Vomiting
Time frame: 2 hrs postoperative
Incidence of Nausea and Vomiting
Time frame: 24hrs postoperative
3 secondary outcomes
Incidence of Hypotension
Time frame: intraoperative - predelivery
Incidence of Hypotension
Time frame: intraoperative - postdelivery
Neonatal Acidosis
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29209926George 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald B George, MD FRCPC principal investigator
IWK Health Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine bolus and phenylephrine infusion in people with Hypotension, run by IWK Health Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Nausea and Vomiting (time frame: intraoperative 2-3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.