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]

Prediction of hypotension caused by spinal block in caesarean section by the analysis of the activity of the autonomic nervous system, and the effects of pharmacological prophylaxis of hypotension on foetal well-being: a double-blinded prospective clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13251047

Enrollment

Registered

2012-02-20

Start date

2011-12-13

Completion date

Unknown

Last updated

2017-11-27

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

Conditions

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

Interventions

For the anaesthetic technique and management, the interventions included will be crystalloid preload with Ringer Lactate 1000 ml, puncture in site position in L3-4 or L2-3 with Withacre G25 or G27 nee

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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)	—

Measure

Time frame

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 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)

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026