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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 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 110 participants.
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
Interventions
- DRUG Phenylephrine
- DRUG Ephedrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2006-07 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00458003
The ClinicalTrials.gov registry entry for NCT00458003 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Phenylephrine is the first listed.
NCT00458003 reports 0 study locations.
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.
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