Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

NCT04481503 | Completed

• 1 other identifier: D20144
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This echocardiography study will characterize heart structure and function during labor. Imaging of the heart during the stress of labor could increase detection of subclinical cardiovascular disease using advanced imaging techniques. Cardiac serum biomarkers and complication rates will also be measured and compared between patients with and without evidence of cardiovascular disease on echocardiography.

Conditions

Obstetric Labor Complications; Cardiovascular Diseases in Pregnancy; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (2)

• The proportion of patients with an abnormal strain pattern as compared to parturients not in labor

  Left ventricular strain

  During echocardiogram procedure

• The proportion of patients with diastolic dysfunction as compared to parturients not in labor

  Abnormal diastolic function

  During echocardiogram procedure

Secondary Outcomes (1)

• Estimated right ventricular systolic pressure

  During echocardiogram procedure

Other Outcomes (25)

• Left ventricular systolic function

  During echocardiogram procedure

• Left ventricular myocardial performance index

  During echocardiogram procedure

• Total number of patients with the presence of regional wall motion abnormalities

  During echocardiogram procedure

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Any pregnant patient, even if gender identity is male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy women between 18 and 35 years of age with singleton pregnancy in active labor

You may qualify if:

• All healthy parturients 18 years of age or older with estimated gestation greater than or equal to 37 weeks who are expected to deliver during their hospitalization.
• During the echocardiographic exam, the patient must be in active labor with cervical dilation between 6-10 cm and contractions that are spaced less than 5 minutes apart.

You may not qualify if:

• Known functional or structural heart disease
• Previously diagnosed pulmonary hypertension.
• Comorbid disease other than diet controlled gestational diabetes, uncomplicated obesity, mild asthma and euthyroid patients with a history of hypo or hyperthyroidism.
• Parturients endorsing active use of non-prescription mind-altering drugs including cocaine, methamphetamine, or ketamine.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 22, 2020
• Study Start: September 5, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)