EUCTR2006-004858-25-GB
Active, not recruiting
Phase 1
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 section
Royal Free Hampstead NHS Trust0 sites75 target enrollmentDecember 11, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Royal Free Hampstead NHS Trust
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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