Supine Versus Left Lateral Tilted Position During Cesarean Delivery
Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.
1 other identifier
interventional
450
1 country
1
Brief Summary
In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2017
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
June 7, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2019
CompletedJuly 9, 2018
July 1, 2018
1.6 years
June 7, 2017
July 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
30 minutes after spinal anesthesia
Secondary Outcomes (10)
severe postspinal hypotension
30 minutes after spinal anesthesia
Post-delivery hypotension
10 minutes after delivery
systolic blood pressure
60 minutes after spinal block
diastolic blood pressure
60 minutes after spinal block
heart rate
60 minutes after spinal block
- +5 more secondary outcomes
Study Arms (2)
supine position
PLACEBO COMPARATORthe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position
Left lateral tilted position
EXPERIMENTALthe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position
Interventions
the patient will be placed in regular supine position after spinal anesthesia
the patient will be placed in left lateral tilted position after spinal anesthesia
The patient will receive 10 mg Bupivacaine for spinal anesthesia
Eligibility Criteria
You may qualify if:
- full term
- singleton pregnant women
- scheduled for elective cesarean delivery
You may not qualify if:
- Cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- baseline systolic blood pressure (SBP) \< 100 mmHg
- body mass index \> 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed Mukhtar, Professor
Head of research committee section in anesthesia department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
June 7, 2017
First Posted
June 9, 2017
Study Start
June 12, 2017
Primary Completion
January 15, 2019
Study Completion
January 20, 2019
Last Updated
July 9, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share