A randomised study to see if two drugs that increase blood pressure, namely phenylephrine and metaraminol, are equally effective to preventing blood pressure falls and in resulting in a healthy baby, at the time of spinal anaesthesia for elective caesarean sectio

Phase 4

Completed

• Conditions: eonatal acid-base status.; Anaesthesia for elective caesarean section; Neonatal acid-base status.; Anaesthesiology - Anaesthetics; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12612000996864
• Lead Sponsor: King Edward Memorial Hospital for Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

1.Women undergoing elective Caesarean section
under spinal or combined spinal epidural (CSE)
anaesthesia
2.Gestational age > 37 weeks
3.Singleton pregnancy
4.ASA I and II
5.Height between 150 and 190 cm
6.Weight between 50 and 115 kg
7.Body mass index (BMI) between 20 and 35 kg/m2

Exclusion Criteria

1.Contraindication to spinal or CSE anaesthesia
2.Diabetes mellitus
3.Preeclampsia, pregnancy-induced hypertension or
essential hypertension
4.Cardiovascular or cerebrovascular disease
5.Fetal abnormality or intrauterine growth restriction
6.Failure to establish block to cold to T4
7.Supplementary epidural anaesthesia prior to
delivery of the baby
8.Conversion to general anaesthesia
9.Excessive shivering that makes blood pressure
monitoring unreliable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eonatal acid-base status at birth, as determined by uterine artery pH.[Cord blood taken at time of birth.]

Secondary Outcome Measures

Name	Time	Method
terine venous pH, pCO2, pO2, standard base excess; p(A-V)CO2 difference, and incidence of umbilical venous pH < 7.20[Cord blood taken at time of birth.];Incidence of maternal hypotension (defined as a reduction in systolic blood pressure by at least 10% below baseline, using an automated sphygmomanometer).[From injection of spinal anaesthetic drugs until delivery of the neonate];Incidence of maternal bradycardia (defined as a fall in heart rate below 60 beats per minute, using a pulse oximeter)[From injection of spinal anaesthetic drugs until delivery of the neonate];Incidence of maternal hypertension (defined as an increase in systolic blood pressure of at least 10% above baseline, using an automated sphygmomanometer).[From injection of spinal anaesthetic drugs until delivery of the neonate];Neonatal Apgar scores at 1 and 5 minutes.[1 and 5 minutes after birth of the neonate]