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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


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 oxygenation

Foetal heartrate

Secondary outcome:

Mean arterial pressure

Cardiac output

Umbilical cord pH and Base excess


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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