Study to compare maternal cardiovascular stability with different phenylephrine dosing regimens used to maintain baseline systolic blood pressure following a spinal anaesthetic for elective caesarean section. - Phenylephrine infusion study for c sectio

Phase 1

• Conditions: We are studying healthy pregnant women undergoing planned caesarean section under spinal anaesthesia. We are investigating ways of reducing hypotension due to spinal anaesthesia by comparing 3 different phenylephrine infusion regimens. Phenylephrine is a drug routinely used in many obstetric anaesthesia centres to counteract hypotension.

• Registration Number: EUCTR2006-004858-25-GB
• Lead Sponsor: Royal Free Hampstead NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

1. Pregnant patients in good general health (ASA physical status 1 or 2)
2. Subject to be greater than 37 weeks gestation
3. Singleton uncomplicated pregnancy
4. Booked to deliver by elective caesarean section (Grade4) under spinal anaesthesia

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Circulatory disease
2. Cardiac disease / medications (e.g. beta blockers)
3. Pregnancy related disease (e.g. preeclampsia or pregnancy induced hypertension)
4. In active labour
5. Presenting for emergency caesarean section
6. Fetal abnormalities
7. Contraindications to spinal anaesthesia
8. Height greater than 180 cm or height less than 150 cm
9. Weight greater than 120 kg or weight less than 50 kg
10. Non-English speaking patients
11. Patient refusal to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our primary endpoint will be to evaluate changes in cardiac output with these 3 phenylephrine infusion regimens. Cardiac output will be evaluated using a suprasternal Doppler cardiac output monitor. In this way we will determine which of the 3 regimens provides the most stable cardiovascular stability.;Secondary Objective: Secondary endpoints would be to evaluate changes in blood pressure and heart rate as well as fetal outcome in terms of umbilical cord blood gases.;Primary end point(s): Our primary endpoint will be to evaluate changes in cardiac output with these 3 phenylephrine infusion regimens.