Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-06 @ 12:59 PM
Study NCT ID:
NCT03701633
Status:
UNKNOWN
Last Update Posted:
2018-12-27
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Artery Doppler Changes Prior and After Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-25', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpartum uterine artery doppler changes prior and after breastfeeding.', 'timeFrame': 'One year', 'description': 'To determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': 'We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.', 'detailedDescription': 'There is emerging evidence linking abnormal UtA Doppler indices in the postpartum period as a risk factor for developing future cardiovascular disorders. Thus far, no study considered the postpartum physiology itself as a possible confounder. If one wishes to draw conclusions about future cardiovascular risk, the role of oxytocin as a confounder must be determined. In the current study, we aim to determine whether oxytocin, physiologically produced during breastfeeding, has an effect on the UtA Doppler measurements in the postpartum period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Every woman who had vaginal delivery, instrumental delivery or cesarean section.', 'genderDescription': 'Postpartum women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n-Every woman who had vaginal delivery, instrumental delivery or cesarean section.\n\nExclusion Criteria:\n\n-Patient's refusal, women who decided not to breastfeed, women who wish to breastfeed, but in whom no milk production commenced yet."}, 'identificationModule': {'nctId': 'NCT03701633', 'briefTitle': 'Uterine Artery Doppler Changes Prior and After Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Postpartum Uterine Artery Doppler Changes Prior and After Breastfeeding', 'orgStudyIdInfo': {'id': '0340-17-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prior to breastfeeding - cross section', 'description': 'Measurements of the UtA doppler postpartum ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session.', 'interventionNames': ['Diagnostic Test: Postpartum ultrasound']}, {'label': 'After breastfeeding - cross section', 'description': 'Measurements of the UtA doppler postpartum ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session.', 'interventionNames': ['Diagnostic Test: Postpartum ultrasound']}], 'interventions': [{'name': 'Postpartum ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurements of the UtA doppler ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session.', 'armGroupLabels': ['After breastfeeding - cross section', 'Prior to breastfeeding - cross section']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yaniv Zipori, MD', 'role': 'CONTACT', 'email': 'y_zipori@rambam.health.gov.il', 'phone': '0587966963'}], 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yaniv Zipori, M.D', 'role': 'CONTACT', 'email': 'y_zipori@rambam.health.gov.il', 'phone': '+972 58 7966963'}], 'overallOfficials': [{'name': 'Yaniv Zipori, M.D', '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': 'Doctor Yaniv Zipori', 'investigatorFullName': 'Yaniv Zipori MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}