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Completed

NCT Number: NCT04481503

Transthoracic Echocardiography of Ventricular 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.

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Key information

Conditions

Obstetric Labor Complications Cardiovascular Diseases in Pregnancy Cardiovascular Risk Factor Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: During echocardiogram procedure

    Left ventricular strain

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

    Time frame: During echocardiogram procedure

    Abnormal diastolic function

Secondary outcomes

  1. Estimated right ventricular systolic pressure

    Time frame: 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)

Other outcomes

  1. Left ventricular systolic function

    Time frame: During echocardiogram procedure

    Simpson's method of discs motion abnormalities and diastolic function

  2. Left ventricular myocardial performance index

    Time frame: During echocardiogram procedure

  3. Total number of patients with the presence of regional wall motion abnormalities

    Time frame: During echocardiogram procedure

  4. Total number of patients with abnormal global right ventricular dysfunction

    Time frame: During echocardiogram procedure

  5. Right ventricular strain

    Time frame: During echocardiogram procedure

    %

  6. Tricuspid annular plane systolic excursion

    Time frame: During echocardiogram procedure

    centimeters

  7. Tissue doppler s'

    Time frame: During echocardiogram procedure

    cm/sec

  8. Total number of maternal deaths within 0-42 days post-partum

    Time frame: 0 to 42 days post-partum

  9. The number of patients with an identifiable Centers for Disease Control Severe Maternal Morbidity Identification complication post-partum

    Time frame: 0 to 42 days 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

  10. The number of patients with a pulse oximetry reading <90% after delivery

    Time frame: 0 to 42 days post-partum

  11. The number of patients who required oxygen administration after delivery

    Time frame: 0 to 42 days post-partum

  12. The number of patients who develop atrial fibrillation or premature atrial complexes

    Time frame: 0 to 42 days post-partum

  13. The number of patients who develop a stroke

    Time frame: 0 to 42 days post-partum

    Stroke must be verified by imaging including either computed tomography or magnetic resonance imaging.

  14. The number of patients with an elevation in transaminase levels during labor or after delivery

    Time frame: 0 to 42 days post-partum

  15. Hospital length of stay

    Time frame: 0 to 42 days post-partum

    Total hours from admission to discharge

  16. The number of patients requiring intensive care unit admission within 42 days post delivery

    Time frame: 0 to 42 days post-partum

  17. Mortality within 42 days post delivery

    Time frame: 0 to 42 days post-partum

  18. The number of patients with a post-partum diagnosis of post-partum hemorrhage

    Time frame: 0 to 42 days post-partum

  19. The total number of patients who require additional uterotonic medications other than oxytocin after delivery

    Time frame: 0 to 42 days post-partum

    Medications include additional dosage of oxytocin above 3 units, methylergonovine, carboprost, tranexamic acid or misoprostol

  20. The number of patients requiring a transfusion

    Time frame: 0 to 42 days post-partum

    Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate

  21. Blood loss

    Time frame: 0 to 42 days post-partum

    Estimated and quantitated blood loss as well as the difference between pre-delivery hemoglobin and post-delivery lowest hemoglobin during admission

  22. Number of patients requiring vasopressor after delivery to support blood pressure

    Time frame: 0 to 42 days post-partum

    phenylephrine, ephedrine, norepinephrine, epinephrine, vasopressin, inhaled nitrous oxide, inhaled epoprostenol

  23. Activin A level

    Time frame: Less than 3 hours after echocardiogram procedure

  24. Placental Growth Factor

    Time frame: Less than 3 hours after echocardiogram procedure

  25. Soluble endoglin

    Time frame: Less than 3 hours after echocardiogram procedure

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Transthoracic Echocardiography of Cardiac Function of Parturients in Labor

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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