Phenylephrine Versus Ephedrine in Pre-eclampsia

Pre-eclampsia Clinical Trial

Official title:

Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02025426
• Other study ID #: Pro00032812
• Status: Terminated
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: July 8, 2016

Study information

• Verified date: September 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 8, 2016
• Est. primary completion date: July 8, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• English speaking

• Age =18 yrs

• Pre-eclampsia (mild, or severe)

• Non-laboring women

• CD under spinal anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Phenylephrine

• Ephedrine

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal Umbilical Cord Gases, pCO2	Partial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord.	Within 5 minutes after delivery
Other	Neonatal Umbilical Cord Gases, pH	Used to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions.	Within 5 minutes after delivery
Other	Neonatal Umbilical Cord Gases, BE	The amount of strong acid (in mmol/L) that needs to be added in vitro to 1 liter of fully oxygenated blood in order to return the sample to standard (normal) conditions (pH 7.40, pCO2 40 mmHg and temperature 37 °C.)	Within 5 minutes after delivery
Other	Number of Participants With Intraoperative Hypotension		Intraoperatively from spinal placement till 10 minutes after delivery
Other	Number of Participants With Intraoperative Nausea		Intraoperatively from time of spinal placement until end of surgery
Other	Number of Participants With Intraoperative Vomiting		Intraoperatively from time of spinal placement until end of surgery
Primary	Cerebral Tissue Oxygen Saturation		Intraoperative from spinal placement till 10 min after delivery
Secondary	Cardiac Output		Intraoperative from spinal placement till 10 min after delivery