CompletedNot Applicable

Maternal Lateral Tilt and Cardiac Output in Caesarean Section

Italy46 participantsStarted 2020-06-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pregnant patients at term (36th to 40th week of gestation) scheduled for elective caesarean section under spinal anesthesia. Exclusion Criteria: * age \<18 years * American Society of Anesthesiologists score \>3 * cardiac arrhythmias or aortic regurgitation * pregnancy-induced hypertension * pre-eclampsia * body mass index (BMI) \> 35 kg/m2 * foetal complications * coagulation disorders or contraindication to neuraxial block * emergency surgery * preoperative infection * patient's refusal

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiac Output (l/min) measured by non-invasive hemodynamic monitoring

Timeframe: at 5 minutes from left lateral uterine tilt removal under spinal anesthesia

Trial details

NCT IDNCT05143684

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-07-31

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