Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-02-27 @ 11:20 AM
Study NCT ID:
NCT02574494
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2015-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2015-10-04', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure measurement', 'timeFrame': 'Up to 16 months', 'description': 'Blood pressure will be measured using millimeters of mercury (mmHg).'}], 'primaryOutcomes': [{'measure': 'Decrease in blood pressure after breastfeeding', 'timeFrame': 'Up to 16 months', 'description': 'A decrease of 15mmHg systolic, 10mmHg diastolic, or a decrease of 10% from baseline will be considered significant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breastfeeding', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.', 'detailedDescription': "Patients included in this study will have chosen to breastfeed.\n\n1. The investigators will identify patients that are planning to breastfeed from their intake questionnaire that all patients receive upon admission to labor and delivery. They will also identify breastfeeding patients while performing our postpartum rounding.\n2. The investigators will perform a chart review to determine their co-morbidities and current medications. Specifically, the patient information recorded will be age, parity, gestational age, delivery route, vital signs, medications, race, whether they are breastfeeding. Of note, all of the individuals listed to participate in this study have routine access to the patient's charts since they will be working with the patients regardless of their participation in the study.\n3. Only hypertensive women will be included. Hypertension is defined as persistent Systolic blood pressure \\> 140 and or persistent diastolic blood pressure \\> 90.\n4. Once it has been determined that they have met the inclusion criteria for the study the investigators will ask the patient's attending physician if we can approach the patient and explain the study and obtain consent.\n5. Once consent is obtained, the investigators will inform the nurse. The patient will have her blood pressure taken prior to breastfeeding, during breastfeeding, and 1-2 hours after breastfeeding. This will occur 3 times in the postpartum period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include breastfeeding mothers that have met criteria for hypertension.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The inclusion criteria include hypertensive women in the first 72 hours postpartum. The gestational age at delivery must be greater or equal to 34wk and the patient must be breastfeeding and/or pumping milk. The study will include patient's on anti-hypertensive. The study will also include patients receiving postpartum IV magnesium but they will have their blood pressure taken two times while on magnesium and two times after the magnesium has been discontinued.\n\nExclusion Criteria:\n\n* The study will exclude patient's on dopamine agonist medications or HIV positive."}, 'identificationModule': {'nctId': 'NCT02574494', 'briefTitle': 'Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients', 'orgStudyIdInfo': {'id': 'Pro00040747'}}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Sarah Kilpatrick', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}