NCT02032355

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

January 7, 2014

Last Update Submit

January 9, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • value of PetCO2 and changes in artery pressure

    up to 4 weeks

Study Arms (1)

hypotension

Procedure: spinal anesthesia

Interventions

hypotension

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

American Society of Anesthesiologists physical status I and II patients undergoing elective cesarean delivery under combined spinal-epidural (CSE) anesthesia

You may qualify if:

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

You may not qualify if:

  • emergency cases
  • placenta praevia
  • preeclampsia
  • cardiovascular or cerebrovascular disease
  • morbid obesity with a BMI≥40
  • contraindications to spinal anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics & Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200090, China

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations