The Oxygenation of the Brain During Caesarean Section
Information source: Naestved Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complications; Cesarean Section
Intervention: Ephedrine (Drug); Phenylephrine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Naestved Hospital Official(s) and/or principal investigator(s):
Visti Foss, Principal Investigator, Affiliation: Naestved Hospital
Summary
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on
organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The
organ perfusion is estimated by measuring the maternal cerebral oxygenation by
NIRS(Near-infrared spectroscopy)and the foetal heartrate.
Clinical Details
Official title: The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frontal lobe cerebral oxygenationFoetal heartrate
Secondary outcome: Mean arterial pressureCardiac output Umbilical cord pH and Base excess
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy pregnant women
- Over 18 years old
- ASA 1-2
- Undergoing elective caesarean section
- Height over 160 cm or under 180 cm
Exclusion Criteria:
- Allergic reactions to ephedrine or phenylephrine
- High blood levels of bilirubin
- HELPP syndrome
- Preeclampsia (pregnancy-induced hypertension)
- Non singleton pregnancies
Locations and Contacts
Naestved Hospital, Naestved 4700, Denmark
Additional Information
Starting date: February 2012
Last updated: August 5, 2012
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