Pre-eclampsiaPhase 4NCT02025426
Phenylephrine Versus Ephedrine in Pre-eclampsia
A Phase 4 study testing Phenylephrine and Ephedrine in people with Pre-eclampsia, run by Duke University at 1 site in United States.
Trial summary
Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- Phenylephrine and Ephedrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 8 Jul 2016
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English speaking
- Age ≥18 yrs
- Pre-eclampsia (mild, or severe)
- Non-laboring women
- CD under spinal anesthesia
Who cannot join
- Height < 5'0"
- Allergy to phenylephrine or ephedrine, or any other standardized medication
- Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV)
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- History of recent amphetamine or cocaine use.
- 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
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia
Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.
- Conditions
- Pre-eclampsia
- Being tested
- Phenylephrine, Ephedrine
- Keywords
- Cesarean delivery, Spinal Anesthesia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
EphedrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Active comparator | Phenylephrine for maintaining blood pressure within 10 % of baseline Receives: Drug: Phenylephrine |
| Ephedrine | Active comparator | Ephedrine for maintaining blood pressure within 10 % of baseline Receives: Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Tissue Oxygen Saturation
Measured: Intraoperative from spinal placement till 10 min after delivery
Secondary outcomes (1)
Cardiac Output
Measured: Intraoperative from spinal placement till 10 min after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startSep 2012
- Primary completion8 Jul 2016
- Study completion8 Jul 2016
Why it stopped: Significant challenges recruiting a difficult patient population with most surgeries occurring out of hours
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.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf S Habib, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025426
- Sponsor's protocol ID
- Pro00032812
- Status last verified
- Sep 2020
- First submitted
- 26 Dec 2013
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia
- ClinicalTrials.gov ID
- NCT02025426
- Acronym / sponsor ID
- Pro00032812
- Conditions
- Pre-eclampsia
- Keywords
- Cesarean delivery, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant challenges recruiting a difficult patient population with most surgeries occurring out of hours
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 8 Jul 2016 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine for maintaining blood pressure within 10 % of baseline |
| Ephedrine | Active comparator | Drug: EphedrineEphedrine for maintaining blood pressure within 10 % of baseline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English speaking
- Age ≥18 yrs
- Pre-eclampsia (mild, or severe)
- Non-laboring women
- CD under spinal anesthesia
Key exclusion criteria (7 listed)
- Height < 5'0"
- Allergy to phenylephrine or ephedrine, or any other standardized medication
- Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV)
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- History of recent amphetamine or cocaine use.
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 | Drug | Phenylephrine |
| Ephedrine | Drug | Ephedrine |
Primary outcome
Cerebral Tissue Oxygen Saturation
Time frame: Intraoperative from spinal placement till 10 min after delivery
1 secondary outcome
Cardiac Output
Time frame: Intraoperative from spinal placement till 10 min after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ashraf S Habib, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine and Ephedrine in people with Pre-eclampsia, run by Duke University at 1 site in United States.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 14 Oct 2020). 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?
Cerebral Tissue Oxygen Saturation (time frame: Intraoperative from spinal placement till 10 min after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.