Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT04060667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2019-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Wireless Physiologic Monitoring in Postpartum Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D063130', 'term': 'Maternal Death'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adeline_boatin@mgh.harvard.edu', 'phone': '617 724 61320', 'title': 'Adeline Boatin', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Until hospital discharge, an average of 3 days', 'description': 'Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Wireless physiologic monitoring: The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.', 'otherNumAtRisk': 1552, 'deathsNumAtRisk': 1552, 'otherNumAffected': 0, 'seriousNumAtRisk': 1552, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Control', 'description': 'Standard of Care monitoring', 'otherNumAtRisk': 1629, 'deathsNumAtRisk': 1629, 'otherNumAffected': 0, 'seriousNumAtRisk': 1629, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Hysterectomy', 'notes': 'Removal of the uterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1552, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1629, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Re-operation', 'notes': 'Need for re-operation after the initial surgery (cesarean delivery)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1552, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1629, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ICU admission', 'notes': 'admission to the intensive care unit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1552, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1629, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac arrest', 'notes': 'need for cardiopulmonary resuscitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1552, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1629, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Maternal Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Wireless physiologic monitoring: The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days', 'description': 'The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was restricted to participants consenting for participation (intervention group) or with completed medical record review (control group)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Wireless Physiologic Monitoring'}, {'id': 'FG001', 'title': 'Control', 'description': 'Standard of Care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1552'}, {'groupId': 'FG001', 'numSubjects': '1639'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1477'}, {'groupId': 'FG001', 'numSubjects': '1629'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'preAssignmentDetails': 'This is a study in which a single health facility was assigned to alternating two-week "intervention" and "control" periods. During the intervention periods, participants were consented, and received the study intervention. During the control periods, participants received standard of care and medical record review only was performed. Consent was waived for participants in the control periods.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Wireless physiologic monitoring: The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Standard of Care monitoring'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3181', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of pregnancies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational Age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1546', 'groupId': 'BG000'}, {'value': '1629', 'groupId': 'BG001'}, {'value': '3175', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.1', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '39.2', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'completed weeks of gestation', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-20', 'size': 415751, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-19T10:42', 'hasProtocol': True}, {'date': '2021-09-26', 'size': 288467, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-19T10:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'describe time blocks, include description of time allotment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3191}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2019-07-31', 'resultsFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-19', 'studyFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Maternal Outcome', 'timeFrame': 'From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days', 'description': 'The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vital sign monitoring', 'maternal near miss', 'maternal mortality', 'maternal morbidity', 'physiologic monitoring', 'quality of care', 'inpatient monitoring'], 'conditions': ['Maternal Death During Childbirth', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '33579213', 'type': 'DERIVED', 'citation': 'Boatin AA, Ngonzi J, Wylie BJ, Lugobe HM, Bebell LM, Mugyenyi G, Mohamed S, Martinez K, Musinguzi N, Psaros C, Metlay JP, Haberer JE. Wireless versus routine physiologic monitoring after cesarean delivery to reduce maternal morbidity and mortality in a resource-limited setting: protocol of type 2 hybrid effectiveness-implementation study. BMC Pregnancy Childbirth. 2021 Feb 12;21(1):124. doi: 10.1186/s12884-021-03550-w.'}]}, 'descriptionModule': {'briefSummary': 'To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital', 'detailedDescription': 'Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth. Despite significant increases in facility-based childbirth, quality gaps at the facility have limited reductions in maternal deaths. Infrequent monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions. Simple increases in staffing will not overcome this gap, thus necessitating new strategies.\n\nThis project aims to use a simple wireless monitor to improve the detection of complications immediately after childbirth and allow clinicians to provide life-saving interventions when needed. Using a hybrid clinical effectiveness-implementation approach women delivered by cesarean in Mbarara, Uganda will be recruited to wear a wireless physiologic monitor for 24 hours after delivery and their delivering obstetricians recruited to use the monitoring system, including the receipt of text message alerts should women develop abnormalities in physiologic signs. Rates of morbidity and mortality will be compared with a control group of women delivered by the same obstetricians. Clinical adoption and implementation will be assessed with the RE-AIM implementation framework and semi-structured interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency cesarean delivery at MRRH\n* Able to provide consent or have a guardian/attendant present who can consent\n* Willing to wear the biosensor for 24 hours\n* Willing remain in the postpartum unit for 24 hours\n\nExclusion Criteria:\n\n* Admitted to ICU directly after delivery\n* Allergies or hypersensitivity to device materials'}, 'identificationModule': {'nctId': 'NCT04060667', 'acronym': 'WIMS', 'briefTitle': 'Wireless Physiologic Monitoring in Postpartum Women', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Wireless Physiologic Monitoring in Postpartum Women', 'orgStudyIdInfo': {'id': '2019P000885'}, 'secondaryIdInfos': [{'id': 'K23HD097300-01', 'link': 'https://reporter.nih.gov/quickSearch/K23HD097300-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants in the intervention arm were monitored for up to 24 hours after an emergency cesarean section using the Current Health wireless physiologic monitoring system, which includes a wearable biosensor that records heart rate, temperature, respiratory rate, oxygen saturation, and movement continuously and transmits data in real-time via a wireless network to the cloud.', 'interventionNames': ['Combination Product: Wireless physiologic monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Participants in the control arm had standard of care monitoring, using available tools on the wards (manual heart rate, temperature, and respiratory rate calculations).'}], 'interventions': [{'name': 'Wireless physiologic monitoring', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['vital sign abnormality alerts'], 'description': 'The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Mbarara Regional Referral Hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Adeline A Boatin, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of OB/GYN', 'investigatorFullName': 'Adeline A Boatin', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}