Condition category
Pregnancy and Childbirth
Date applied
23/01/2012
Date assigned
20/02/2012
Last edited
03/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hypotension (low blood pressure) can be caused by the use of a spinal block (anaesthetic) during a caesarean section. The drug phenylephrine can be used to prevent hypotension. The aim of this study is to compare the ability of different indicators to predict hypotension in caesarian section, and to assess the effects of phenylephrine on foetal well-being.

Who can participate?
Pregnant women scheduled for caesarean section

What does the study involve?
Participants are randomly allocated to be treated with either phenylephrine or placebo (dummy drug) and ephedrine if necessary to treat the hypotension. Foetal well-being is assessed through a blood sample from the umbilical cord.

What are the possible benefits and risks of participating?
There are no known risks to participants, except for the usual side effects related to phenylephrine or caesarian section.

Where is the study run from?
Hospital Universitario Miguel Servet (Spain)

When is the study starting and how long is it expected to run for?
December 2011 to September 2013

Who is funding the study?
Aragon Institute of Health Sciences (Spain)

Who is the main contact?
Dr Augusto Navarro Hernando

Trial website

Contact information

Type

Scientific

Primary contact

Dr Augusto Navarro Hernando

ORCID ID

Contact details

Seccion de Anestesia
Hospital Universitario Miguel Servet
Paseo Isabel La Católica 1-3
Zaragoza
50009
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC 10/060

Study information

Scientific title

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

Acronym

Study hypothesis

Prophylaxis of hypotension with phenylephrine has negative effects on the pH of umbilical cord in pregnant women who are not prone to develop hypotension, which offsets the potential positive impact of prevention on the pH of cord of patients prone to develop it. The hemodynamic stress of the decubitus supine position (supine stress test) can induce additional changes in the autonomic nervous system (ANS), which would improve the ability of heart rate variability (HRV) analysis of prediction of the hypotension. The simultaneous study of different indicators and modes of analysis of the activity of the ANS and its variations between bed rest and supine stress will make it possible to identify the component of the spectrum of frequency variability and the indicator that is best able to predict hypotension.

Ethics approval

The Clinical Research Ethics Committee of Aragon [Comité Ético de Investigación Clínica de Aragón (CEICA)], 27/07/2011, ref: C.I.EC10/060

Study design

Prospective clinical double-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Caesarean section and hypotension after spinal block

Intervention

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 needle, block with Bupivacaine 0.5% hyperbaric (10 mg in height <155cm, 11mg in height 155-165 cm, 12 mg in >165 cm) with 0.15 mg of morphic chlorure conservant free addition. Supine position with 45º left tilt. Maintenance of the venous with a Ringer Lactated infusion at 15 ml/kr-1•min-1.

If the patient is assigned to treatment group, they will receive a parallel infusion of phenylephrine through an infusion bomb at 1 ml•kg-1•min-1 for the hypotension prophylaxis, and if the patient is assigned to control group will only receive a placebo infusion. The hypotension treatment will consist of an ephedrine intravenous bolus correction in both groups if necessary, with an initial 5 mg dose, and adding additional bolus if the hypotension does not stop.

Intervention type

Drug

Phase

Not Applicable

Drug names

Phenylephrine

Primary outcome measures

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

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)

Overall trial start date

13/12/2011

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

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

Recruitment start date

13/12/2011

Recruitment end date

01/09/2013

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario Miguel Servet
Zaragoza
50009
Spain

Sponsor information

Organisation

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

Sponsor details

Avenida Gómez Laguna 25
Planta 11
Zaragoza
50009
Spain

Sponsor type

Research organisation

Website

http://www.ics.aragon.es/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/11/2017: Plain English summary added.