Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT03478267
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AChE levels in fetal blood', 'timeFrame': 'Up to 5 minutes post delivery (either vaginal or cesarean)', 'description': 'AChE levels obtained from the fetal umbilical cord after birth'}], 'secondaryOutcomes': [{'measure': 'AChE levels in maternal blood', 'timeFrame': 'Up to 5 minutes post delivery (either vaginal or cesarean)', 'description': 'AChE levels obtained from maternal peripheral blood after birth'}, {'measure': 'AChE levels in the placenta', 'timeFrame': 'Up to 30 minutes post delivery (either vaginal or cesarean)', 'description': 'AChE levels obtained from the placenta after birth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Heart Failure (Disorder)']}, 'descriptionModule': {'briefSummary': "Pregnant women between 32-41 weeks' gestation designated for either vaginal birth or cesarean section will be recruited for the study. Data regarding maternal resting heart rate and fetal baseline heart rate as depicted on the monitor will be collected. A blood sample will be acquired from the parturient and the umbilical cord as well as a sample from the placenta will be obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all aforementioned samples. Statistical correlation between fetal baseline heart rate and fetal and maternal AChE levels will be assessed.", 'detailedDescription': "Pregnant women between 32-41 weeks' gestation designated for either vaginal birth or cesarean section will be recruited for the study. After signing an informed consent, data regarding maternal resting heart rate and fetal baseline heart rate as depicted on the monitor will be collected.\n\nPatients will be divided into 2 equal groups according to fetal baseline heart rate:\n\n1. st group-fetal heart rate between 110-130 beats per minute (bpm).\n2. nd group-fetal heart rate between 140-160 bpm. A blood sample will be acquired from the parturient and the umbilical cord as well as a sample from the placenta will be obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all aforementioned samples. Statistical correlation between fetal baseline heart rate and fetal and maternal AChE levels will be assessed.\n\nData regarding demographic, medical and obstetric information of the participants will be obtained from the hospital's electronic records."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Pregnant women between 32 and 41 weeks' gestation undergoing either vaginal or cesarean delivery with a fetal baseline heart rate of 110-130 beats per minute and 140-160 beats per minute.", 'genderDescription': 'Female pregnant patients and their fetuses', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women between 32 and 41 weeks' gestation undergoing either vaginal or cesarean delivery with a fetal baseline heart rate of 110-130 beats per minute and 140-160 beats per minute.\n\nExclusion Criteria:\n\n1. Delivery before 32 weeks of gestation\n2. Maternal bradycardic (\\<60) or tachycardic (\\>100) resting heart rate.\n3. Fetal bradycardia (\\<110) or tachycardia (\\>160).\n4. Suspected chorioamnionitis\n5. Maternal diseases which can affect her heart rate such as:\n\n 1. Cardiac disease (including arrhythmias)\n 2. Diseases of the thyroid gland\n 3. Rheumatic diseases\n6. Use of medication which alters heart rate such as:\n\n 1. Beta blockers\n 2. Beta agonists\n 3. Cocaine, amphetamines\n7. Use of Pethidine and Phenergan during delivery"}, 'identificationModule': {'nctId': 'NCT03478267', 'briefTitle': 'The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood', 'orgStudyIdInfo': {'id': '0584-16-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fetal heart rate 110-130 bpm', 'description': 'Pregnancies in which the fetal baseline heart rate is between 110 beats per minute and 130 beats per minute.', 'interventionNames': ['Diagnostic Test: AChE levels']}, {'label': 'Fetal heart rate 140-160 bpm', 'description': 'Pregnancies in which the fetal baseline heart rate is between 140 beats per minute and 160 beats per minute.', 'interventionNames': ['Diagnostic Test: AChE levels']}], 'interventions': [{'name': 'AChE levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.', 'armGroupLabels': ['Fetal heart rate 110-130 bpm', 'Fetal heart rate 140-160 bpm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam hospital', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Vered Lamhot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary investigator', 'investigatorFullName': 'Vered Lamhot MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}