Supine Versus Left Lateral Tilted Position During Cesarean Delivery

Study Overview
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Brief Summary
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In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position

Detailed Description
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Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.

Official Title
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Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Other: supine position
* Other: left lateral tilted position
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: full term singleton pregnant women scheduled for elective cesarean delivery Exclusion Criteria: Cardiac morbidities hypertensive disorders of pregnancy peripartum bleeding baseline systolic blood pressure (SBP) < 100 mmHg body mass index > 35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: supine position<br>the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position | Other: supine position<br>* the patient will be placed in regular supine position after spinal anesthesia<br>Drug: Bupivacaine<br>* The patient will receive 10 mg Bupivacaine for spinal anesthesia<br>* Other names: Marcaine;|
| Experimental: Left lateral tilted position<br>the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position | Other: left lateral tilted position<br>* the patient will be placed in left lateral tilted position after spinal anesthesia<br>Drug: Bupivacaine<br>* The patient will receive 10 mg Bupivacaine for spinal anesthesia<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe postspinal hypotension | The number of patients who develop hypotension (defined as decreased SBP less than 60% 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 | 
| Post-delivery hypotension | number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion | 10 minutes after delivery | 
| systolic blood pressure | systolic blood pressure measured in mmHg | 60 minutes after spinal block | 
| diastolic blood pressure | diastolic blood pressure measured in mmHg | 60 minutes after spinal block | 
| heart rate | heart rate measured in beats per minute | 60 minutes after spinal block | 
| incidence of nausea and vomiting | number of patients who develop nausea and vomiting divided by the total number of patients in the group | 60 minutes after spinal block | 
| ephedrine consumption | total amount of ephedrine consumed during the operation (measured in milligrams) | 60 minutes after spinal block | 
| Atropine consumption | total amount of atropine consumed during the operation (measured in milligrams | 60 minutes after spinal block | 
| APGAR score | APGAR score for detection of the well being of the fetus | 1 minute after delivery | 
| APGAR score | APGAR score for detection of the well being of the fetus | 10 minute after delivery |