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NCT00458003 · ClinicalTrials.gov registry record · NA

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients

A NA study, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
110
Enrollment target

NCT00458003: Completed NA study, sponsored by Northwestern University.

NCT00458003 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 110 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00458003, a NA study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
110 participants
Enrollment target

Study Summary

Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women

Primary Outcome

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.

Interventions

  • DRUG Phenylephrine
  • DRUG Ephedrine

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2006-07
Est. Completion 2016-12
Phase NA
Northwestern University

1,209 total trials

What the finished NCT00458003 record still lists

NCT00458003 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Phenylephrine is the first listed.

NCT00458003 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00458003 about?

NCT00458003 is a clinical study titled "Phenylephrine in Spinal Anesthesia in Preeclamptic Patients". Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice becau...

What is the current status of trial NCT00458003?

This trial is currently completed. It is a NA study. The enrollment target is 110 participants. The study started on 2006-07. Estimated completion is 2016-12.

What interventions are being tested in trial NCT00458003?

The interventions under investigation include: Phenylephrine (DRUG), Ephedrine (DRUG).

Who is sponsoring clinical trial NCT00458003?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00458003's enrollment target sits among peer trials

110 816th of 2000 higher than 1,176 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00458003, the US trial registry maintained by the National Library of Medicine. NCT00458003 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.