Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

Transthoracic Echocardiography of Cardiac Function of Parturients in Labor

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular myocardial performance index		During echocardiogram procedure
Total number of patients with the presence of regional wall motion abnormalities		During echocardiogram procedure
Total number of patients with abnormal global right ventricular dysfunction		During echocardiogram procedure
Tricuspid annular plane systolic excursion	centimeters	During echocardiogram procedure
Tissue doppler s'	cm/sec	During echocardiogram procedure
Total number of maternal deaths within 0-42 days post-partum		0 to 42 days post-partum
The number of patients with an identifiable Centers for Disease Control Severe Maternal Morbidity Identification complication post-partum	Acute myocardial infarction, aortic aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, ventricular fibrillation, conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, heart failure, arrest during surgery or procedure, puerperal cerebrovascular disorders, pulmonary edema, aspiration, cardiopulmonary anesthesia complications, sepsis, shock, air or thrombotic embolism, blood product transfusion, hysterectomy, temporary tracheostomy, requiring ventilation	0 to 42 days post-partum
The number of patients with a pulse oximetry reading <90% after delivery		0 to 42 days post-partum
The number of patients who required oxygen administration after delivery		0 to 42 days post-partum
The number of patients who develop atrial fibrillation or premature atrial complexes		0 to 42 days post-partum
The number of patients who develop a stroke	Stroke must be verified by imaging including either computed tomography or magnetic resonance imaging.	0 to 42 days post-partum
The number of patients with an elevation in transaminase levels during labor or after delivery		0 to 42 days post-partum
Hospital length of stay	Total hours from admission to discharge	0 to 42 days post-partum
The number of patients requiring intensive care unit admission within 42 days post delivery		0 to 42 days post-partum
Mortality within 42 days post delivery		0 to 42 days post-partum
The number of patients with a post-partum diagnosis of post-partum hemorrhage		0 to 42 days post-partum
The total number of patients who require additional uterotonic medications other than oxytocin after delivery	Medications include additional dosage of oxytocin above 3 units, methylergonovine, carboprost, tranexamic acid or misoprostol	0 to 42 days post-partum
The number of patients requiring a transfusion	Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate	0 to 42 days post-partum
Blood loss	Estimated and quantitated blood loss as well as the difference between pre-delivery hemoglobin and post-delivery lowest hemoglobin during admission	0 to 42 days post-partum
Number of patients requiring vasopressor after delivery to support blood pressure	phenylephrine, ephedrine, norepinephrine, epinephrine, vasopressin, inhaled nitrous oxide, inhaled epoprostenol	0 to 42 days post-partum
Activin A level		Less than 3 hours after echocardiogram procedure
Placental Growth Factor		Less than 3 hours after echocardiogram procedure
Soluble endoglin		Less than 3 hours after echocardiogram procedure
Left ventricular systolic function	Simpson's method of discs motion abnormalities and diastolic function	During echocardiogram procedure
Right ventricular strain	%	During echocardiogram procedure

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2020
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 18, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Cardiovascular Diseases; Obstetric Labor Complications
• Other Study ID Numbers: D20144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No