Clinical trial NCT04481503: Transthoracic Echocardiography of Ventricular Function of Parturients in Labor
Official title: Transthoracic Echocardiography of Cardiac Function of Parturients in Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Labor Complications
Cardiovascular Diseases in Pregnancy
Cardiovascular Risk Factor
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women between 18 and 35 years of age with singleton pregnancy in active labor

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients with an abnormal strain pattern as compared to parturients not in labor
timeFrame: During echocardiogram procedure
measure: The proportion of patients with diastolic dysfunction as compared to parturients not in labor
timeFrame: During echocardiogram procedure
Secondary outcomes:
measure: Estimated right ventricular systolic pressure
timeFrame: During echocardiogram procedure
Other outcomes:
measure: Left ventricular systolic function
timeFrame: During echocardiogram procedure
measure: Left ventricular myocardial performance index
timeFrame: During echocardiogram procedure
measure: Total number of patients with the presence of regional wall motion abnormalities
timeFrame: During echocardiogram procedure
measure: Total number of patients with abnormal global right ventricular dysfunction
timeFrame: During echocardiogram procedure
measure: Right ventricular strain
timeFrame: During echocardiogram procedure
measure: Tricuspid annular plane systolic excursion
timeFrame: During echocardiogram procedure
measure: Tissue doppler s'
timeFrame: During echocardiogram procedure
measure: Total number of maternal deaths within 0-42 days post-partum
timeFrame: 0 to 42 days post-partum
measure: The number of patients with an identifiable Centers for Disease Control Severe Maternal Morbidity Identification complication post-partum
timeFrame: 0 to 42 days post-partum
measure: The number of patients with a pulse oximetry reading <90% after delivery
timeFrame: 0 to 42 days post-partum
measure: The number of patients who required oxygen administration after delivery
timeFrame: 0 to 42 days post-partum
measure: The number of patients who develop atrial fibrillation or premature atrial complexes
timeFrame: 0 to 42 days post-partum
measure: The number of patients who develop a stroke
timeFrame: 0 to 42 days post-partum
measure: The number of patients with an elevation in transaminase levels during labor or after delivery
timeFrame: 0 to 42 days post-partum
measure: Hospital length of stay
timeFrame: 0 to 42 days post-partum
measure: The number of patients requiring intensive care unit admission within 42 days post delivery
timeFrame: 0 to 42 days post-partum
measure: Mortality within 42 days post delivery
timeFrame: 0 to 42 days post-partum
measure: The number of patients with a post-partum diagnosis of post-partum hemorrhage
timeFrame: 0 to 42 days post-partum
measure: The total number of patients who require additional uterotonic medications other than oxytocin after delivery
timeFrame: 0 to 42 days post-partum
measure: The number of patients requiring a transfusion
timeFrame: 0 to 42 days post-partum
measure: Blood loss
timeFrame: 0 to 42 days post-partum
measure: Number of patients requiring vasopressor after delivery to support blood pressure
timeFrame: 0 to 42 days post-partum
measure: Activin A level
timeFrame: Less than 3 hours after echocardiogram procedure
measure: Placental Growth Factor
timeFrame: Less than 3 hours after echocardiogram procedure
measure: Soluble endoglin
timeFrame: Less than 3 hours after echocardiogram procedure
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: