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Supine Versus Left Lateral Tilted Position During Cesarean Delivery

Phase 4
Conditions
Cesarean Section Complications
Interventions
Other: supine position
Other: left lateral tilted position
Drug: Bupivacaine
Registration Number
NCT03182114
Lead Sponsor
Cairo University
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

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
450
Inclusion Criteria
  • full term
  • singleton pregnant women
  • scheduled for elective cesarean delivery
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Exclusion Criteria
  • Cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • baseline systolic blood pressure (SBP) < 100 mmHg
  • body mass index > 35
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
supine positionsupine positionthe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position
Left lateral tilted positionleft lateral tilted positionthe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position
supine positionBupivacainethe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position
Left lateral tilted positionBupivacainethe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position
Primary Outcome Measures
NameTimeMethod
postspinal hypotension30 minutes after spinal anesthesia

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

Secondary Outcome Measures
NameTimeMethod
severe postspinal hypotension30 minutes after spinal anesthesia

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

Post-delivery hypotension10 minutes after delivery

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

systolic blood pressure60 minutes after spinal block

systolic blood pressure measured in mmHg

diastolic blood pressure60 minutes after spinal block

diastolic blood pressure measured in mmHg

incidence of nausea and vomiting60 minutes after spinal block

number of patients who develop nausea and vomiting divided by the total number of patients in the group

ephedrine consumption60 minutes after spinal block

total amount of ephedrine consumed during the operation (measured in milligrams)

Atropine consumption60 minutes after spinal block

total amount of atropine consumed during the operation (measured in milligrams

heart rate60 minutes after spinal block

heart rate measured in beats per minute

APGAR score10 minute after delivery

APGAR score for detection of the well being of the fetus

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Egypt

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