Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

Caesarean Section;Stillbirth Clinical Trial

— NECS  

Official title:

Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245891
• Other study ID #: IRB 17.11.01
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. The main objective is to compare the initial Apgar score. The records of patients who received norepinephrine are compared to those without norepinephrine. To limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, ASA score, comorbidity, urgency. The patients analysed correspond to the period 2016-2017.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• age > 18

• Spinal Anesthesia for Cesarean Section

Exclusion Criteria:

• sub epidural cesarean section

• contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)

Related Conditions & MeSH terms

• Caesarean Section;Stillbirth
• Stillbirth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lactate level	The primary endpoint is the Umbilical Cord Lactate levels	Just after the birth of the newborn baby
Secondary	APGAR Score	APGAR Score	1, 5 and 10 minutes after birth
Secondary	Umbilical Cord arterial PH	Umbilical Cord arterial PH	Just after the birth
Secondary	Umbilical Cord venous PH	Umbilical Cord venous PH	Just after the birth
Secondary	maternal arterial tension during cesarean section	maternal arterial tension during cesarean section	0, 5,10,15, 20 25, 30,35,40 minutes after spinal anesthesia
Secondary	incidences of mother nausea and vomiting	incidences of mother nausea and vomiting	from beginning to cesarean section end
Secondary	use of vasopressors	use of vasopressors	from beginning to cesarean section end