Supine Versus Left Lateral Tilted Position During Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03182114
• Other study ID #: N-52-2017
• Status: Recruiting
• Phase: Phase 4
• Start date: June 12, 2017
• Est. completion date: January 20, 2019

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: Ahmed Shash, Professor
• Phone: +201001033999
• Email: shashahmed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 20, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Other:
• supine position
the patient will be placed in regular supine position after spinal anesthesia
• left lateral tilted position
the patient will be placed in left lateral tilted position after spinal anesthesia

Drug:
• Bupivacaine
The patient will receive 10 mg Bupivacaine for spinal anesthesia

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	systolic blood pressure	systolic blood pressure measured in mmHg	60 minutes after spinal block
Secondary	diastolic blood pressure	diastolic blood pressure measured in mmHg	60 minutes after spinal block
Secondary	heart rate	heart rate measured in beats per minute	60 minutes after spinal block
Secondary	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
Secondary	ephedrine consumption	total amount of ephedrine consumed during the operation (measured in milligrams)	60 minutes after spinal block
Secondary	Atropine consumption	total amount of atropine consumed during the operation (measured in milligrams	60 minutes after spinal block
Secondary	APGAR score	APGAR score for detection of the well being of the fetus	1 minute after delivery
Secondary	APGAR score	APGAR score for detection of the well being of the fetus	10 minute after delivery