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Clinical Trials/EUCTR2006-004858-25-GB
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.

Registry
who.int
Start Date
December 11, 2008
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Royal Free Hampstead NHS Trust

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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