NCT05143684

Maternal Lateral Tilt and Cardiac Output in Caesarean Section

Completed Last updated 3 December 2021

What this trial tests

trial testing Left Lateral Uterine Displacement in Hypotension Drug-Induced in 46 participants. Completed in 31 July 2020.

Timeline

1 June 2020

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Completed
Study type	OBSERVATIONAL
Enrollment	46
Start date	1 June 2020
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	1 location across Italy

Drugs / interventions tested

• Left Lateral Uterine Displacement

Conditions studied

• Hypotension Drug-Induced — all drugs for Hypotension Drug-Induced →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Hypotension Drug-Induced. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Left uterine displacement (LUD) has been questioned as an effective strategy to prevent aortocaval compression after spinal anesthesia (SA) for cesarean delivery (CD). The investigators tested if LUD has a significant impact on cardiac output (CO) in patients undergoing CD under SA during continuous non-invasive hemodynamic monitoring.

Methods: Forty-six patients were included in the final analysis. The investigators considered 4 timepoints of 5 minutes each: T1=baseline with LUD; T2=baseline without LUD; T3=after SA with LUD; T4=after SA without LUD. LUD was then repositioned for CD. Primary outcome was to test if CO decreased from T3 to T4. We also compared CO between T1 and T2 and other hemodynamic variables: mean, systolic and diastolic blood pressure (respectively MAP, SAP and DAP), heart rate (HR), stroke volume (SV), stroke volume variation (SVV), pulse pressure variation (PPV), contractility (dP/dt), dynamic arterial elastance (Eadyn) at the different timepoints. Data on fetal Apgar scores and umbilical arterial and venous pH were collecte

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of maternal lateral tilt on cardiac output during caesarean section under spinal anaesthesia: a prospective observational study.
   Sonnino C, Frassanito L, Piersanti A, Giuri PP, et al · · 2022 · cited 3× · PMID 35410115 · DOI 10.1186/s12871-022-01640-6
2. Impact of Maternal Lateral Tilt On Cardiac Output During Caesarean Section Under Spinal Anaesthesia: A Prospective Observational Study
   Sonnino C, Frassanito L, Piersanti A, Giuri PP, et al · · 2022 · DOI 10.21203/rs.3.rs-1149869/v1