Skip to main content
OpenTrials
Completed

NCT Number: NCT01509521

The Oxygenation of the Brain During Caesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complications; Cesarean Section

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Naestved Hospital

Næstved, 4700, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine

Drug

An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.

Other names: Efedrin, Ephedrine hydrochloride

Phenylephrine

Drug

An infusion of maximum 4 mg/hour for maximum 60 minutes.

Other names: Phenylephrine Hydrochloride, Metaoxedrin

Primary outcomes

  1. Frontal lobe cerebral oxygenation

    Time frame: 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.

  2. Foetal heartrate

    Time frame: 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

Secondary outcomes

  1. Mean arterial pressure

    Time frame: 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.

  2. Cardiac output

    Time frame: 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.

  3. Umbilical cord pH and Base excess

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine

Acronym: OBDUC

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2012
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.