Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 10:43 AM
Study NCT ID:
NCT06813859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005316', 'term': 'Fetal Distress'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fetal heart rate', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': 'The fetal heart rate is continuously monitored via the CTG device during the entire performance test.'}], 'secondaryOutcomes': [{'measure': 'Umbilical cord artery pulsatility index', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(systolic velocity - diastolic velocity) / mean velocity'}, {'measure': 'Umbilical cord artery resistance index', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(systolic velocity - diastolic velocity) / systolic velocity'}, {'measure': 'umbilical cord artery S/D ratio', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(S = maximum systolic flow velocity; D = maximum diastolic flow velocity)'}, {'measure': 'Medial cerebral artery pulsatility index', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(systolic velocity - diastolic velocity) / mean velocity'}, {'measure': 'Medial cerebral artery resistance index', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(systolic velocity - diastolic velocity) / systolic velocity'}, {'measure': 'medial cerebral artery peak systolic velocity', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': 'in cm/s'}, {'measure': 'right and left uterine artery pulsatility index', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(systolic velocity - diastolic velocity) / mean velocity'}, {'measure': 'right and left uterine artery resistance index', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': '(systolic velocity - diastolic velocity) / systolic velocity'}, {'measure': 'cerebro-placental ratio', 'timeFrame': 'through exercise testing, an average of 90 minutes', 'description': 'pulsatility index of the middle cerebral artery / pulsatility index of the umbilical artery'}, {'measure': 'pregnancy complications', 'timeFrame': 'during pregnancy and up to12 weeks after birth', 'description': 'incidence of pregnancy complications (yes/no);'}, {'measure': 'birth complications', 'timeFrame': 'On the day the child is born', 'description': 'incidence of birth complications (yes/no);'}, {'measure': 'mode of delivery', 'timeFrame': 'On the day the child is born', 'description': 'spontaneous birth vs. vacuum-assisted birth vs. forceps-assisted birth vs planned cesarean section vs. unplanned cesarean section'}, {'measure': 'APGAR score', 'timeFrame': 'On the day the child is born', 'description': 'APGAR score (1-10)'}, {'measure': 'gestational age at birth', 'timeFrame': 'On the day the child is born', 'description': 'gestational age at birth (in weeks and days);'}, {'measure': 'pH value of the umbilical cord artery', 'timeFrame': 'On the day the child is born', 'description': 'pH value of the umbilical cord artery mesured directly after birth'}, {'measure': 'fetal admission to Neonatal Intensive Care Unit', 'timeFrame': 'up to 12 weeks', 'description': 'admission (yes/no)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Distress']}, 'descriptionModule': {'briefSummary': 'Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.', 'detailedDescription': 'The aim of the study is to evaluate in a preliminary step the validity of fetal heart rate measurement with the "Nemo Healthcare Monitoring System" - a wireless non-invasive CTG device. Furthermore, we will determine the reliability for CTG measurements (intraobserver and interobserver reliability) and for ultrasound (intraobserver reliability). The device is approved for use on pregnant women and is regularly used as a CTG device for monitoring fetal heart rate and contractions during childbirth. If in the preliminary step the heart rate measurements with the "Nemo Fetal Monitoring System" provide valid and fetal heart rate results compared to the standard Doppler ultrasound method and provide a reliable detection of fetal heart rate deceleration the effects of phys-ical activity on fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply rate will be investigated in the main part of the study in a larger study population.\n\nIt is hypothesized that CTG provides technically a valid and reliable continuous re-cording of fetal heart rate values, since fetal heart rate measurement under physical exertion has previously only been possible by intermittent but not continuous Dop-pler ultrasound. Furthermore, we will evaluate alterations in fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply according to the level of exertion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant athletes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of signed informed consent form\n* healthy pregnant active female over the age of 18 years and below 45 years\n* sporting activity \\>4h/week on 2 or more weekdays\n* single pregnancy, between 28+0 and 34+0 weeks of pregnancy\n\nExclusion Criteria:\n\n* No signed informed consent form or revocation of consent\n* pre-existing pregnancy complications'}, 'identificationModule': {'nctId': 'NCT06813859', 'briefTitle': 'Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device', 'orgStudyIdInfo': {'id': '2023-01380'}}, 'armsInterventionsModule': {'interventions': [{'name': 'exercise testing', 'type': 'OTHER', 'description': 'incremental cycling test on a bicycle ergometer'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nora Wieloch, Dr. med.', 'role': 'CONTACT', 'email': 'nora.wieloch@balgrist.ch', 'phone': '0041443861111'}, {'name': 'Nina Kimmich, PD Dr. med.', 'role': 'CONTACT', 'email': 'nina.kimmich@usz.ch', 'phone': '0041442551111'}], 'overallOfficials': [{'name': 'Johannes Scherr, Prof. Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Centre for Prevention and Sports Medicine, Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Zürich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}