The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
1 other identifier
interventional
105
1 country
1
Brief Summary
The investigators intend to study the impact of patient positioning on the changes in blood pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that the changes in blood pressure relate to the speed with which the spinal medication rises. By slowing the rise of spinal anesthesia, the investigators believe that the incidence and severity of hypotension might be reduced.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 4, 2017
January 1, 2017
3.3 years
May 19, 2014
January 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in blood pressure
percentage change in blood pressure after spinal anesthesia
20 minutes
Secondary Outcomes (1)
IV fluid administration
20 minutes
Other Outcomes (1)
IV pressor requirements
20 minutes
Study Arms (3)
Lateral
ACTIVE COMPARATORpatient placed in the lateral postion for spinal anesthesia
Sitting
ACTIVE COMPARATORpatient placed in the sitting position for spinal anestheisa, then supine
Recline
ACTIVE COMPARATORpatient placed in the sitting position for spinal anesthesia administration. After spinal placed, the patient turned to a 30-degree upperbody tilt, followed by a slow recline to supine over 5 minutes
Interventions
Eligibility Criteria
You may qualify if:
- Singleton pregnancy
- Term gestation
- Scheduled cesarean delivery
- Spinal anesthesia for delivery
You may not qualify if:
- Significant fetal concerns
- Polyhydramnios
- Macrosomia
- Morbid obesity (BMI \>40)
- Chronic hypertension
- Gestational hypertension
- Preeclampsia
- Type 1 diabetes
- Contraindications to spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Obstetric Anesthesia
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 26, 2014
Study Start
September 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 4, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share