Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial
1 other identifier
interventional
140
1 country
1
Brief Summary
Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedStudy Start
First participant enrolled
January 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2017
CompletedFebruary 24, 2017
February 1, 2017
1 month
November 29, 2016
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hypotension
caesarean delivery
Secondary Outcomes (2)
heart rate
caesarean delivery
Newborn APGAR
Turn off of the newly born: measured to the 1 and 5 minutes from the birth
Other Outcomes (2)
Nausea
surgical procedure
Vomiting
surgical procedure
Study Arms (2)
group 1
EXPERIMENTALPhenylephrine 40 mcg/min, infusion during 5 minutes
group 2
PLACEBO COMPARATORSaline solution 21 cc, infusion during 5 minutes
Interventions
prophylactic infusion of phenylephrine 40 mcg/min
Eligibility Criteria
You may qualify if:
- pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
- Gestational age \>37 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic materno infaltil San Luis
Bucaramanga, Santander Department, 68003, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hector Meléndez, Dr
Universidad Industrial de Santander
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 1, 2016
Study Start
January 17, 2017
Primary Completion
February 20, 2017
Study Completion
February 21, 2017
Last Updated
February 24, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share