Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02979405
• Date of registration: 29/11/2016
• Prospective Registration: Yes
• Primary sponsor: Universidad Industrial de Santander
• Public title: Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
• Scientific title: Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial
• Date of first enrolment: January 17, 2017
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02979405
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

Colombia

Contacts

• Name: Hector Meléndez, Dr
• Affiliation: Universidad Industrial de Santander

Key inclusion & exclusion criteria

Inclusion Criteria:

- pregnant subjects who are to be delivered to cesarean section under subarachnoid
anesthesia

- Gestational age >37 weeks

Exclusion Criteria:

Pregnant subjects with:

- Hipertensive disorders in pregnancy

- Acute fetal distress

- Evidence of placental dysfunction

- History of cardiovascular or cerebrovascular diseases

- hypersensitivity to phenylephrine

- Rejection of the patient



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypotension Drug-Induced

Intervention(s)

Drug: Phenylephrine

Primary Outcome(s)

Hypotension [Time Frame: caesarean delivery]

Secondary Outcome(s)

Newborn APGAR [Time Frame: Turn off of the newly born: measured to the 1 and 5 minutes from the birth]

heart rate [Time Frame: caesarean delivery]

Secondary ID(s)

UIS 2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors