The Oxygenation of the Brain During Caesarean Section

Phase 4

Completed

• Conditions: Complications; Cesarean Section
• Interventions: Drug: Ephedrine; Drug: Phenylephrine

• Registration Number: NCT01509521
• Lead Sponsor: Naestved Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-08
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Study Start: 2012-02
• Primary Completion: 2012-07
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-05
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine	Ephedrine	-
Phenylephrine	Phenylephrine	-

Primary Outcome Measures

Name	Time	Method
Foetal heartrate	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	From before induction of spinal anaesthesia to 15 min after delivery
Frontal lobe cerebral oxygenation	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery.
Umbilical cord pH and Base excess	Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.	The umbilical cord blood analysis for evaluation of the newborn's acid-base status is taken immediately after delivery. It is the most objective way of assessing the fetal metabolic condition at birth.
Cardiac output	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	The cardiac output is measures from before induction of spinal anaesthesia to end of surgery.

Trial Locations

Locations (1)

Naestved Hospital; 🇩🇰 Naestved, Denmark