NCT03555799

Brief Summary

The investigators propose this study to test the hypotheses that inferior vena cava (IVC) diameter can predict hypotension after labor analgesia (epidural, combined spinal-epidural) and neuraxial anesthesia for cesarean section (epidural, combined spinal-epidural and spinal block) in full-term pregnant patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

May 18, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

June 1, 2018

Last Update Submit

July 1, 2019

Conditions

Pregnancy RelatedHypotension, Orthostatic

Outcome Measures

Primary Outcomes (1)

  • IVC diameter

    IVC diameter in centimeters during respiratory cycle

    10 minutes

Secondary Outcomes (2)

  • Mean arterial pressure

    30 minutes

  • Nausea

    30 minutes

Study Arms (1)

Labor analgesia patients

Patients with clinical indication of labor epidural will have IVC diameter measurement with ultrasound before and after the epidural placement

Diagnostic Test: Inferior vena cava ultrasound

Interventions

Inferior vena cava ultrasoundDIAGNOSTIC_TEST

Abdominal ultrasound to identify IVC between hepatic veins and right atrium. Measurement of dimensions throughout respiratory cycle (before and after labor epidural)

Labor analgesia patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParturients in labor
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Term pregnant patients in labor who have labor epidural placement.

You may qualify if:

  • Pregnant patients \>37 weeks of gestation
  • Indication for neuraxial labor analgesia or regional anesthesia for cesarean section
  • Age older than 18 years
  • Pregnancy without diagnosed comorbidities

You may not qualify if:

  • Unwillingness to participate in the study
  • Diagnosis of Hypertensive disorders of pregnancy
  • Diagnosis of cardiopulmonary disease
  • Allergy to US gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Anesthesiology and Perioperative Medicine

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 14, 2018

Study Start

May 18, 2018

Primary Completion

May 31, 2019

Study Completion

June 15, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)