Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 2:20 AM
Study NCT ID:
NCT05457504
Status:
UNKNOWN
Last Update Posted:
2022-07-18
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this study, we are testing different strategies to help women decrease issues with hypertension in the postpartum period. Participants may or may not undergo some of the following study procedures:\n\n* Frequent blood pressure monitoring and feedback\n* Receive information related to blood pressure measurement, heart disease prevention, etc.\n* Regular blood pressure monitoring and advice regarding changes in medications.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of patients who are normotensive at 6 weeks postpartum by American College of Cardiology (ACC)/American Heart Association (AHA) guidelines', 'timeFrame': '6 weeks', 'description': 'Percent of patients who are normotensive at 6 weeks postpartum by ACC/AHA guidelines (\\>130/80) in each treatment group'}], 'secondaryOutcomes': [{'measure': 'Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines', 'timeFrame': '6 weeks', 'description': 'Percent of patients who are normotensive at 6 weeks postpartum by ACOG guidelines (\\>140/90) in each treatment group'}, {'measure': 'Frequency of Hospital readmission', 'timeFrame': '6 weeks', 'description': 'Frequency of Hospital readmission in the first 6 weeks postpartum in each treatment group'}, {'measure': 'Number of medication titrations', 'timeFrame': '6 weeks', 'description': 'Mean number of medication titrations by patient in the first 6 postpartum weeks in each treatment group'}, {'measure': 'Adherence with scheduled outpatient clinical appointments', 'timeFrame': '6 months', 'description': 'Percent of scheduled outpatient clinical appointments attended by patients in the first 6 postpartum months in each treatment group'}, {'measure': 'Establishment of care with a primary care doctor', 'timeFrame': '1 year', 'description': 'Percent of patients who attend a primary care doctor visit in the first postpartum year in each treatment group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension in Pregnancy', 'Preeclampsia', 'Gestational Hypertension', 'Chronic Hypertension With Pre-Eclampsia', 'Hypertension Complicating Pregnancy, Childbirth, and the Puerperium']}, 'descriptionModule': {'briefSummary': "Cardiovascular disease and hypertensive disorders of pregnancy (HDP) are the leading causes of maternal morbidity and mortality in the United States. Postpartum, in office care has demonstrated to be an insufficient model of hypertensive management postpartum, largely due to barriers that women face in accessing in office care, with stark racial disparities in access. The care of postpartum patients with HDP following delivery is made up of either a single postpartum visit at 6 weeks postpartum or a fragmented and non-standardized series of in-person appointments depending on the patients' medical complications and the clinicians' experience. Further, current society guidelines outline inpatient thresholds for initiation of antihypertensive medication but do not provide recommendations for titration thereafter. The proposed study will investigate the acceptability and effectiveness of an algorithm-based, outpatient treatment model for the management of postpartum hypertension utilizing an asynchronous text-based platform as compared to the standard of care for postpartum women with a diagnosis of Hypertensive disorder of pregnancy at Massachusetts General Hospital."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of gestational hypertension (Systolic Blood Pressure (SBP)≥140 or Diastolic Blood Pressure (DBP) ≥90 on at least two occasions at least 4 hours apart after 20 weeks gestation in previously normotensive women) and or preeclampsia (SBP≥140 or DBP ≥90, proteinuria with or without symptoms of preeclampsia (headache, vision changes, right upper quadrant pain), and presentation of symptoms/lab abnormalities but no proteinuria)\n* English and Spanish-speaking\n* Delivering at Massachusetts General Hospital\n\nExclusion Criteria:\n\n* Chronic hypertension or underlying cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT05457504', 'briefTitle': 'Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension', 'orgStudyIdInfo': {'id': '2021P003705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Behavioral: Remote blood pressure monitoring']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Remote blood pressure monitoring', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to this arm will participate in the experimental intervention', 'armGroupLabels': ['Experimental']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to this arm will participate in a placebo intervention', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ilona T Goldfarb, MD', 'role': 'CONTACT', 'email': 'igoldfarb@partners.org', 'phone': '617-724-2640'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ilona T. Goldfarb, M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}