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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01509521
Other study ID # 2011-006103-35
Secondary ID SJ-271
Status Completed
Phase Phase 4
First received January 8, 2012
Last updated August 5, 2012
Start date February 2012
Est. completion date August 2012

Study information

Verified date August 2012
Source Naestved Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ephedrine
An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.
Phenylephrine
An infusion of maximum 4 mg/hour for maximum 60 minutes.

Locations

Country Name City State
Denmark Naestved Hospital Naestved

Sponsors (2)

Lead Sponsor Collaborator
Naestved Hospital Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frontal lobe cerebral oxygenation Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery. Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour Yes
Primary Foetal heartrate From before induction of spinal anaesthesia to 15 min after delivery Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour Yes
Secondary Mean arterial pressure The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery. Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour Yes
Secondary Cardiac output The cardiac output is measures from before induction of spinal anaesthesia to end of surgery. Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour Yes
Secondary Umbilical cord pH and Base excess 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. Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes. Yes
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