Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-25 @ 2:38 PM
Study NCT ID:
NCT04289350
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2020-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Day to Day Variation in Fetal Heart Rate Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root mean square of successive inter beat interval differences (RMSSD)', 'timeFrame': '1/8-2020', 'description': 'Time domain analysis'}, {'measure': 'Standard deviation of normal to normal inter beat interval (SDNN)', 'timeFrame': '1/8-2020', 'description': 'Time domain analysis'}, {'measure': 'High frequency power (HF-power)', 'timeFrame': '1/8-2020', 'description': 'Spectral analysis'}, {'measure': 'Low frequency power (LF-power)', 'timeFrame': '1/8-2020', 'description': 'spectral analysis'}, {'measure': 'Low frequency power/High frequency power (LF/HF)', 'timeFrame': '1/8-2020', 'description': 'Spectral analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fetal Growth Retardation']}, 'descriptionModule': {'briefSummary': 'This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy singleton pregnant women. Danish.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy singleton pregnant women with an expected healthy fetus\n\nExclusion Criteria:\n\n* fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.'}, 'identificationModule': {'nctId': 'NCT04289350', 'acronym': '(FHRV)', 'briefTitle': 'Day to Day Variation in Fetal Heart Rate Variability', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study', 'orgStudyIdInfo': {'id': 'fHRV_2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fetal heart rate variability', 'type': 'DIAGNOSTIC_TEST', 'description': 'An observational study. No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynecology. Aarhus Unive', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation', 'class': 'OTHER'}, {'name': 'Hartmann Fonden', 'class': 'OTHER'}, {'name': 'Augustinus Fonden', 'class': 'OTHER'}, {'name': 'The Dagmar Marshall Foundation', 'class': 'OTHER'}, {'name': 'AP Moeller Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}