Prediction of hypotension caused by spinal block in caesarean section and the effect of of hypotension on foetal well-being [Predicción de la hipotensión del bloqueo espinal de las cesáreas mediante análisis de la actividad del SNA, y efectos de la profilaxis farmacológica de la hipotensión sobre el bienestar fetal]

Not Applicable

Completed

Conditions: Caesarean section and hypotension after spinal block
Pregnancy and Childbirth
Delivery by caesarean section, unspecified

Registration Number: ISRCTN13251047

Lead Sponsor: Aragon Institute of Health Sciences (Instituto Aragonés de Ciencias de la Salud) (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 80

Inclusion Criteria

1. Pregnant women scheduled for caesarean section in first turn on the surgical part
2. Informed consent to participate in the trial asked in the preanaesthetic consultation

Exclusion Criteria

1. Presence of uterine dynamics
2. Multiple pregnancies
3. Maternal pathology related or not with the gestation
4. Suspicion of foetal pathology

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The first part of the trial will study different indicators of the ANS (autonomic nervous system) activity and their arterial hypotension prediction capacity related to the caesarean intervention spinal anaesthesia. The ANS activity will be measured through HRV, PRV and Pulse Transit Time Variability (PTTV) and a digital register of the ECG curve

Secondary Outcome Measures

Name	Time	Method
The second part of the trial is the study of the hypotension prophylaxis with phenylephrine effect on foetal well-being. This will be measured through an arterial and venous blood sample from the umbilical cord to determinate gases, acid-base balance and lactic acid<br>Other measurements will be done, a register and evaluation of the maternal total antioxidant system (TAS), TAM, TAD, FC and oxygen saturation (Sat O2) at baseline and at 5 and 20 minutes of the epinephrine bolus infusion, the number of epinephrine bolus, dose and administration time and the times of epinephrine bolus initiation, uterine incision and foetal extraction, nausea and vomiting (adverse effects)