An observational study in Hypotension, Controlled, Anaesthesia, Spinal and Caesarean Section, sponsored by Papa Giovanni XXIII Hospital. Completed at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Papa Giovanni XXIII Hospital · Observational
Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can be burdened by maternal hypotension with significant maternal and foetal implications.
Hypotension induced by neuraxial anaesthesia (NA-induced hypotension) is defined as systolic blood pressure (SBP) less than 100 mmHg or a decrease of 20-30% from baseline values. The incidence of hypotension could exceed 71% and can cause, if serious and prolonged, nausea, vomiting, lost of consciousness, placental hypoperfusion and foetal acidosis.
There are two alternative hypotheses to explain why hypotension might be so commonly diagnosed after regional analgesia during labour: preload reduction theory and afterload reduction theory. A non-invasive continue haemodynamic monitoring could be useful in detecting pregnant women with a positive preoperative supine stress, at increased risk for clinically significant hypotension during Caesarean section under spinal anaesthesia. These women seem more likely to benefit from optimizing the administration of fluids and vasoconstrictors to maintain pressure and cardiac output at basal levels.
Predictors of clinical need of therapy to counteract symptomatic hypotension (dependant variable) will be sought by using regression logistic analysis. Putative variable to include in the model will be selected through clinical and statistical criteria. Univariate screening will be performed assuming the usual cut-off of p\<0,1 and taking into account the biological relevance. The final variable to challenge in the multivariate model will be selected according to the parsimony criteria in order to avoid overfitting and multicollinearity.
1,023 studies on the registry are indexed under Hypotension; 172 are open to participants now.
This study's enrollment of 55 is below the median of 84 across 301 observational studies indexed under Hypotension.
Browse Hypotension studies →Papa Giovanni XXIII Hospital is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy pregnant women admitted in the enrolling Centre to undergo to elective Caesarean section under spinal anaesthesia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Preeclampsia (defined as gestational hypertension with one or more of the following de novo conditions:
Other maternal organ dysfunction:
Stress tests and Systolic blood pressure
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Stress tests and Diastolic blood pressure
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Diastolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Stress tests and Mean arterial blood pressure
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Mean arterial blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Stress tests and Heart rate
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Heart rate in beats per minute) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Stress tests and Cardiac output
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Cardiac output in L/min) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Stress tests and Stroke volume
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Stroke volume in mL/beat) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Stress tests and Systemic vascular resistance
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systemic vascular resistance in dynes - sec/cm\^5) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
Neuraxial induced hypotension
Neuraxial induced hypotension is defined as a reduction of SBP \< 100 mmHg or a decrease by 20 - 30%, compared to basal value
Time frame: from immediately after induction of spinal anaesthesia to 15 minutes later
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Papa Giovanni XXIII Hospital