Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-02 @ 9:46 AM
Study NCT ID:
NCT05631067
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2022-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014115', 'term': 'Toxemia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Outcome', 'timeFrame': '2 weeks', 'description': 'Detection of elevated BP\\>140/90 mm Hg\n\nDetection of elevated BP\\>140/90 mm Hg'}, {'measure': 'Incidence of combined adverse cardiovascular events', 'timeFrame': '12 weeks', 'description': 'The incidence of a combined adverse cardiovascular endpoint (all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality) at 12-weeks postpartum.'}], 'primaryOutcomes': [{'measure': 'Rate of recruitment', 'timeFrame': 'Through study completion at 1 year', 'description': 'Number of participants recruited'}], 'secondaryOutcomes': [{'measure': 'Fidelity', 'timeFrame': '2 weeks', 'description': '10 daily home BP checks per participant during 2-week study period'}, {'measure': 'Retention', 'timeFrame': '2 weeks', 'description': 'Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertensive Disorder of Pregnancy']}, 'descriptionModule': {'briefSummary': 'Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. About 1 out of every 10 maternal deaths in Sub-Saharan Africa are associated with HDP, and most of these deaths are preventable with timely, implementation of evidence-based strategies, including postpartum blood pressure (BP) monitoring, treatment of elevated BP and comprehensive postpartum follow up as recommended by the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO).\n\nThis study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability of: 1) postpartum remote blood pressure monitoring and 2) NTproBNP testing for postpartum risk stratification in women with HDP at the University of Abuja Teaching Hospital in the Federal Capital Territory of Nigeria', 'detailedDescription': 'Aims:\n\n1. To evaluate the feasibility, fidelity, and acceptability of home blood pressure monitoring in postpartum patients (n=90) with HDP. The investigators hypothesize that remote blood pressure monitoring will be feasible, implemented as intended, and acceptable among patients, physicians, and other health care workers to improve awareness and early diagnosis of elevated blood pressures (\\>140/90 mm Hg) in postpartum patients with HDP.\n2. To evaluate the association between N Terminal-proBNP (NT-proBNP) levels and short-term cardiovascular outcomes (i.e., all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality at 12-weeks postpartum) in patients with HDP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years of age\n* Admitted for delivery\n* Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia)\n\nControl participants:\n\n* Adults \\>18 years of age\n* Admitted for delivery\n* with an uncomplicated pregnancy and delivery\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Unable to check blood pressure at home'}, 'identificationModule': {'nctId': 'NCT05631067', 'briefTitle': 'Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria', 'orgStudyIdInfo': {'id': '#202207009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BP monitoring arm', 'description': 'Participants will be adults \\>18 years of age admitted for delivery with a diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) per the American College of Obstetricians and Gynecologists Criteria.', 'interventionNames': ['Behavioral: Remote blood pressure monitoring', 'Diagnostic Test: NT proBNP assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Control participants will be adults \\>18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP.', 'interventionNames': ['Diagnostic Test: NT proBNP assessment']}], 'interventions': [{'name': 'Remote blood pressure monitoring', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum', 'armGroupLabels': ['BP monitoring arm']}, {'name': 'NT proBNP assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will have biomarker assessment at 0-2 days postpartum', 'armGroupLabels': ['BP monitoring arm', 'Control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwagwalada', 'state': 'Federal Capital Territory', 'country': 'Nigeria', 'facility': 'University of Abuja Teaching Hospital', 'geoPoint': {'lat': 8.94342, 'lon': 7.08165}}], 'overallOfficials': [{'name': 'Zainab Mahmoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Mark D Huffman, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Dike Ojji, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Abuja Teaching Hospital'}, {'name': 'Kathryn Lindley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 1 year of study conclusion', 'ipdSharing': 'YES', 'description': 'IPD will be available within 1 year of study completion', 'accessCriteria': 'Criteria and URL will be provided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Abuja Teaching Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor of Medicine (Principal Investigator)', 'investigatorFullName': 'Zainab Mahmoud', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}