Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT04481503
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2020-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transthoracic Echocardiography of Ventricular Function of Parturients in Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-18', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Left ventricular systolic function', 'timeFrame': 'During echocardiogram procedure', 'description': "Simpson's method of discs motion abnormalities and diastolic function"}, {'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', 'description': '%'}, {'measure': 'Tricuspid annular plane systolic excursion', 'timeFrame': 'During echocardiogram procedure', 'description': 'centimeters'}, {'measure': "Tissue doppler s'", 'timeFrame': 'During echocardiogram procedure', 'description': 'cm/sec'}, {'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', 'description': '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'}, {'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', 'description': 'Stroke must be verified by imaging including either computed tomography or magnetic resonance imaging.'}, {'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', 'description': 'Total hours from admission to discharge'}, {'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', 'description': 'Medications include additional dosage of oxytocin above 3 units, methylergonovine, carboprost, tranexamic acid or misoprostol'}, {'measure': 'The number of patients requiring a transfusion', 'timeFrame': '0 to 42 days post-partum', 'description': 'Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate'}, {'measure': 'Blood loss', 'timeFrame': '0 to 42 days post-partum', 'description': 'Estimated and quantitated blood loss as well as the difference between pre-delivery hemoglobin and post-delivery lowest hemoglobin during admission'}, {'measure': 'Number of patients requiring vasopressor after delivery to support blood pressure', 'timeFrame': '0 to 42 days post-partum', 'description': 'phenylephrine, ephedrine, norepinephrine, epinephrine, vasopressin, inhaled nitrous oxide, inhaled epoprostenol'}, {'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'}], 'primaryOutcomes': [{'measure': 'The proportion of patients with an abnormal strain pattern as compared to parturients not in labor', 'timeFrame': 'During echocardiogram procedure', 'description': 'Left ventricular strain'}, {'measure': 'The proportion of patients with diastolic dysfunction as compared to parturients not in labor', 'timeFrame': 'During echocardiogram procedure', 'description': 'Abnormal diastolic function'}], 'secondaryOutcomes': [{'measure': 'Estimated right ventricular systolic pressure', 'timeFrame': 'During echocardiogram procedure', 'description': 'Comparing estimated right ventricular systolic pressure between patients in active labor as compared to those who are not in active labor (mm Hg)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstetric Labor Complications', 'Cardiovascular Diseases in Pregnancy', 'Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy women between 18 and 35 years of age with singleton pregnancy in active labor', 'genderDescription': 'Any pregnant patient, even if gender identity is male.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Known functional or structural heart disease\n* Previously diagnosed pulmonary hypertension.\n* Comorbid disease other than diet controlled gestational diabetes, uncomplicated obesity, mild asthma and euthyroid patients with a history of hypo or hyperthyroidism.\n* Parturients endorsing active use of non-prescription mind-altering drugs including cocaine, methamphetamine, or ketamine.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04481503', 'briefTitle': 'Transthoracic Echocardiography of Ventricular Function of Parturients in Labor', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Transthoracic Echocardiography of Cardiac Function of Parturients in Labor', 'orgStudyIdInfo': {'id': 'D20144'}}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology', 'investigatorFullName': 'Leigh C. Hickerson', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}