Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

Completed

• Conditions: Obstetric Labor Complications; Cardiovascular Risk Factor; Cardiovascular Diseases in Pregnancy

• Registration Number: NCT04481503
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-18
• Study First Posted: 2020-07-22
• Study Start: 2020-09-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Other non-inclusion criteria include inability to tolerate left lateral positioning either symptomatically or by fetal heart rate monitoring, suspected hypo-or hypercoagulable states that was not previously diagnosed, hemodynamic instability requiring >2 L crystalloid administration within 1 hour time frame after epidural placement or vasopressor administration of >15 mg ephedrine or >300 mcg phenylephrine administration within 1 hour after epidural placement.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with an abnormal strain pattern as compared to parturients not in labor	During echocardiogram procedure	Left ventricular strain
The proportion of patients with diastolic dysfunction as compared to parturients not in labor	During echocardiogram procedure	Abnormal diastolic function

Secondary Outcome Measures

Name	Time	Method
Estimated right ventricular systolic pressure	During echocardiogram procedure	Comparing estimated right ventricular systolic pressure between patients in active labor as compared to those who are not in active labor (mm Hg)

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States