Trial · NCT00458003
Phenylephrine in Spinal Anesthesia in Preeclamptic Patients
NCT00458003, Not applicable, Completed, Northwestern University; results first posted 2022-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phenylephrine in Spinal Anesthesia in Preeclamptic Patients. Trials, record NCT00458003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00458003
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phenylephrine in Spinal Anesthesia in Preeclamptic Patients
- NCT number
- NCT00458003
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 110 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Preeclampsia, Hypotension
- Interventions
- Ephedrine, Phenylephrine
- First posted
- 2007-04-09
- Last updated
- 2022-06-02
- Results first posted
- 2022-06-02
- Limitations and caveats
We assumed that the potency of phenylephrine to ephedrine was 80:1 based on published works. Baseline BP on day of procedure may be elevated due to anxiousness. The definition of preeclampsia as defined by ACOG changed during study period.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Umbilical Artery pH | Immediately after delivery | The umbilical artery blood pH immediately after delivery. The pH scale ranges from 0 to 14. A normal pH sample from the umbilical artery ranges from pH: 7.18 - 7.38. The lower the pH the more acidic and the higher the pH the more basic. |
| Secondary | The Umbilical Artery Blood Base Excess | Immediately after delivery | The umbilical artery blood base excess immediately after delivery. Base excess and base deficit refer to an excess or deficit, in the amount of base present in the blood. The value (-2 to +2 normal range) is usually reported as a concentration in units of mEq/L, with positive numbers indicating an excess of base and negative a deficit |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Umbilical Artery pH | Immediately after delivery | 72 newborn blood samples in the phenylephrine group and 74 newborn blood samples were analyzed (there were multiple gestations in both groups) | pH | MEDIAN |
| SECONDARY | The Umbilical Artery Blood Base Excess | Immediately after delivery | 72 newborn blood samples were obtained from the phenylephrine group and 74 newborn samples were obtained from the ephedrine group ( there were multiple gestations in both groups) | mEq/L | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Umbilical Artery pH | Phenylephrine | 7.22 | Standard Deviation .07 | pH | |
| The Umbilical Artery pH | Ephedrine | 7.20 | Standard Deviation .1 | pH | |
| The Umbilical Artery Blood Base Excess | Phenylephrine | -2.8 | Full Range -4.6 to -2.2 | mEq/L | |
| The Umbilical Artery Blood Base Excess | Ephedrine | -3.4 | Full Range -5.7 to -2.0 | mEq/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phenylephrine | 55 | |
| Overall Study | STARTED | Ephedrine | 55 | |
| Overall Study | COMPLETED | Phenylephrine | 54 | |
| Overall Study | COMPLETED | Ephedrine | 54 | |
| Overall Study | NOT COMPLETED | Phenylephrine | 1 | |
| Overall Study | NOT COMPLETED | Ephedrine | 1 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Reactive hypertension | Vascular disorders | Phenylephrine Mothers | 0 | 54 | 0 |
| other | Reactive hypertension | Vascular disorders | Ephedrine Mothers | 0 | 54 | 0 |
| other | Reactive hypertension | Vascular disorders | Phenylepherine Infants | 0 | 72 | 0 |
| other | Reactive hypertension | Vascular disorders | Ephedrine Infants | 0 | 74 | 0 |
| other | Bradycardia | Cardiac disorders | Phenylephrine Mothers | 0 | 54 | 0 |
| other | Bradycardia | Cardiac disorders | Ephedrine Mothers | 2 | 54 | 2 |
| other | Bradycardia | Cardiac disorders | Phenylepherine Infants | 0 | 72 | 0 |
| other | Bradycardia | Cardiac disorders | Ephedrine Infants | 0 | 74 | 0 |
| other | Nausea | Gastrointestinal disorders | Phenylephrine Mothers | 18 | 54 | 18 |
| other | Nausea | Gastrointestinal disorders | Ephedrine Mothers | 22 | 54 | 22 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenylephrine Mothers | 0 | 54 |
| Total, all-cause mortality | Ephedrine Mothers | 0 | 54 |
| Total, all-cause mortality | Phenylepherine Infants | 0 | 72 |
| Total, all-cause mortality | Ephedrine Infants | 0 | 74 |
| Total, other adverse events | Phenylephrine Mothers | 21 | 54 |
| Total, other adverse events | Ephedrine Mothers | 28 | 54 |
| Total, other adverse events | Phenylepherine Infants | 0 | 72 |
| Total, other adverse events | Ephedrine Infants | 0 | 74 |
| Total, serious adverse events | Phenylephrine Mothers | 0 | 54 |
| Total, serious adverse events | Ephedrine Mothers | 0 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00458003
GET https://conductscience.org/api/trials/v1/NCT00458003/registered