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.

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

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: supine position; Drug: Bupivacaine; Other: left lateral tilted 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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
APGAR score	APGAR score for detection of the well being of the fetus	1 minute after delivery
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
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	10 minute after delivery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Ahmed Mukhtar, Professor, Head of research committee section in anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Anticipated): January 15, 2019
• Study Completion (Anticipated): January 20, 2019

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: N-52-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No