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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03182114
Enrollment
450
Registered
2017-06-09
Start date
2017-06-12
Completion date
2019-01-20
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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.

Interventions

OTHERsupine position

the patient will be placed in regular supine position after spinal anesthesia

OTHERleft lateral tilted position

the patient will be placed in left lateral tilted position after spinal anesthesia

DRUGBupivacaine

The patient will receive 10 mg Bupivacaine for spinal anesthesia

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postspinal hypotension30 minutes after spinal anesthesiaThe 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

MeasureTime frameDescription
Post-delivery hypotension10 minutes after deliverynumber 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 blocksystolic blood pressure measured in mmHg
diastolic blood pressure60 minutes after spinal blockdiastolic blood pressure measured in mmHg
heart rate60 minutes after spinal blockheart rate measured in beats per minute
severe postspinal hypotension30 minutes after spinal anesthesiaThe 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
ephedrine consumption60 minutes after spinal blocktotal amount of ephedrine consumed during the operation (measured in milligrams)
Atropine consumption60 minutes after spinal blocktotal amount of atropine consumed during the operation (measured in milligrams
APGAR score1 minute after deliveryAPGAR score for detection of the well being of the fetus
incidence of nausea and vomiting60 minutes after spinal blocknumber of patients who develop nausea and vomiting divided by the total number of patients in the group

Countries

Egypt

Contacts

Primary ContactAhmed Shash, Professor
shashahmed@gmail.com+201001033999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026