Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04481503
Collaborator
(none)
400
1
70.8
5.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Transthoracic Echocardiography of Cardiac Function of Parturients in Labor
Actual Study Start Date :
Sep 5, 2020
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Outcome Measures

Primary Outcome Measures

  1. The proportion of patients with an abnormal strain pattern as compared to parturients not in labor [During echocardiogram procedure]

    Left ventricular strain

  2. The proportion of patients with diastolic dysfunction as compared to parturients not in labor [During echocardiogram procedure]

    Abnormal diastolic function

Secondary Outcome Measures

  1. 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)

Other Outcome Measures

  1. Left ventricular systolic function [During echocardiogram procedure]

    Simpson's method of discsmotion abnormalities and diastolic function

  2. Left ventricular myocardial performance index [During echocardiogram procedure]

  3. Total number of patients with the presence of regional wall motion abnormalities [During echocardiogram procedure]

  4. Total number of patients with abnormal global right ventricular dysfunction [During echocardiogram procedure]

  5. Right ventricular strain [During echocardiogram procedure]

  6. Tricuspid annular plane systolic excursion [During echocardiogram procedure]

    centimeters

  7. Tissue doppler s' [During echocardiogram procedure]

    cm/sec

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

  11. The number of patients who required oxygen administration after delivery [0 to 42 days post-partum]

  12. The number of patients who develop atrial fibrillation or premature atrial complexes [0 to 42 days post-partum]

  13. The number of patients who develop a stroke [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 [0 to 42 days post-partum]

  15. Hospital length of stay [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 [0 to 42 days post-partum]

  17. Mortality within 42 days post delivery [0 to 42 days post-partum]

  18. The number of patients with a post-partum diagnosis of post-partum hemorrhage [0 to 42 days post-partum]

  19. The total number of patients who require additional uterotonic medications other than oxytocin after delivery [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 [0 to 42 days post-partum]

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

  21. Blood loss [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 [0 to 42 days post-partum]

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

  23. Activin A level [Less than 3 hours after echocardiogram procedure]

  24. Placental Growth Factor [Less than 3 hours after echocardiogram procedure]

  25. Soluble endoglin [Less than 3 hours after echocardiogram procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03766

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leigh C. Hickerson, Assistant Professor of Anesthesiology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT04481503
Other Study ID Numbers:
  • D20144
First Posted:
Jul 22, 2020
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2021