Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

Cardiovascular Risk Factor Clinical Trial

Official title:

Transthoracic Echocardiography of Cardiac Function of Parturients in Labor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481503
• Other study ID #: D20144
• Status: Recruiting
• Start date: September 5, 2020
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Leigh C Hickerson, MD
• Phone: (603) 650-5000
• Email: leigh.c.hickerson[@]hitchcock.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left ventricular systolic function	Simpson's method of discs motion abnormalities and diastolic function	During echocardiogram procedure
Other	Left ventricular myocardial performance index		During echocardiogram procedure
Other	Total number of patients with the presence of regional wall motion abnormalities		During echocardiogram procedure
Other	Total number of patients with abnormal global right ventricular dysfunction		During echocardiogram procedure
Other	Right ventricular strain		During echocardiogram procedure
Other	Tricuspid annular plane systolic excursion	centimeters	During echocardiogram procedure
Other	Tissue doppler s'	cm/sec	During echocardiogram procedure
Other	Total number of maternal deaths within 0-42 days post-partum		0 to 42 days post-partum
Other	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
Other	The number of patients with a pulse oximetry reading <90% after delivery		0 to 42 days post-partum
Other	The number of patients who required oxygen administration after delivery		0 to 42 days post-partum
Other	The number of patients who develop atrial fibrillation or premature atrial complexes		0 to 42 days post-partum
Other	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
Other	The number of patients with an elevation in transaminase levels during labor or after delivery		0 to 42 days post-partum
Other	Hospital length of stay	Total hours from admission to discharge	0 to 42 days post-partum
Other	The number of patients requiring intensive care unit admission within 42 days post delivery		0 to 42 days post-partum
Other	Mortality within 42 days post delivery		0 to 42 days post-partum
Other	The number of patients with a post-partum diagnosis of post-partum hemorrhage		0 to 42 days post-partum
Other	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
Other	The number of patients requiring a transfusion	Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate	0 to 42 days post-partum
Other	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
Other	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
Other	Activin A level		Less than 3 hours after echocardiogram procedure
Other	Placental Growth Factor		Less than 3 hours after echocardiogram procedure
Other	Soluble endoglin		Less than 3 hours after echocardiogram procedure
Primary	The proportion of patients with an abnormal strain pattern as compared to parturients not in labor	Left ventricular strain	During echocardiogram procedure
Primary	The proportion of patients with diastolic dysfunction as compared to parturients not in labor	Abnormal diastolic function	During echocardiogram procedure
Secondary	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