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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02032355
Other study ID # 61538
Secondary ID
Status Recruiting
Phase N/A
First received January 7, 2014
Last updated January 9, 2014
Start date January 2014
Est. completion date February 2014

Study information

Verified date January 2014
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationChina: Ethics Committee
Study type Observational

Clinical Trial Summary

Maternal hypotension is a common side effect after spinal anesthesia for cesarean delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and blood pooling in blocked areas of the body respectively, are main causes of spinal anaesthesia-induced hypotension during Caesarean delivery.

Cardiac output, which has shown to be a better predictor of organ and placental perfusion than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the maternal population.This is largely because of the lack of availability of accurate and reproducible noninvasive measurement techniques. Up to now, preventing hypotension has continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as markers of cardiovascular status, because these are more easily measured.

Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension during spinal anaesthesia, would also have a positive and significant association.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- full-term gestation (>36 and <41 weeks of gestation) with a singleton pregnancy

Exclusion Criteria:

- emergency cases

- placenta praevia

- preeclampsia

- cardiovascular or cerebrovascular disease

- morbid obesity with a BMI=40

- contraindications to spinal anaesthesia

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
spinal anesthesia


Locations

Country Name City State
China Obstetrics & Gynecology Hospital, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Geng guiqi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary value of PetCO2 and changes in artery pressure up to 4 weeks Yes
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