Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-26 @ 6:41 AM
Study NCT ID:
NCT03024905
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2016-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project to Use Community Health Workers to Reduce Maternal Deaths
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063130', 'term': 'Maternal Death'}], 'ancestors': [{'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2016-12-11', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facility births', 'timeFrame': 'During baseline vs during intervention periods until end of study (2 years)', 'description': 'Number of women attending health facilities for delivery'}], 'secondaryOutcomes': [{'measure': 'Antenatal Care visits', 'timeFrame': 'During baseline vs during intervention until end of study (2 years)', 'description': 'Number of times women attend health facility for antenatal visits'}, {'measure': 'Postpartum visits', 'timeFrame': 'During baseline vs during intervention until end of study (2 years)', 'description': 'Number of women attending health facility for postpartum visits'}, {'measure': 'Use of transport intervention', 'timeFrame': 'During Intervention until end of study (2 years)', 'description': 'Number of women using the free transport intervention'}, {'measure': 'Use of birth kit', 'timeFrame': 'During Intervention until end of study (2 years)', 'description': 'Number of women using the birth kit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Maternal Mortality', 'Access to Health Care']}, 'referencesModule': {'references': [{'pmid': '35086508', 'type': 'DERIVED', 'citation': 'Webber G, Chirangi B, Magatti N, Mallick R, Taljaard M. Improving health care facility birth rates in Rorya District, Tanzania: a multiple baseline trial. BMC Pregnancy Childbirth. 2022 Jan 27;22(1):74. doi: 10.1186/s12884-022-04408-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to establish if several interventions will help women in rural Tanzania access health care services during pregnancy and at the time of delivery. The interventions include education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and supplies to be used either at the health facility, or on route if the women does not make it to the health facility.', 'detailedDescription': 'In order to reduce the number of women dying in childbirth and to improve women\'s health in pregnancy, this trial is designed to assess if several interventions combined can increase the number of women delivering in health care facilities. The design of the study is "Multiple Baseline Design". Community health workers are trained to collect baseline data on women using mobile phones in one rural district in Tanzania. The district has four distinct divisions. After 6 months of baseline data in the district, one division will experience the interventions. The interventions are education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and birthing supplies to be used either at the health facility, or on route if the women does not make it to the health facility. The intervention will be begun in each of the other divisions in 3 month intervals (i.e. the second division starts to experience the interventions 3 months after the first, the third, 3 months after the second and the fourth 3 months after the third). The trial will continue for a total of 27 months including the baseline period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women must be pregnant.\n2. Women must live in Rorya District, but not in Shirati Town.\n3. Women must deliver in Rorya District .\n\nExclusion Criteria:\n\n1. Women who live outside or deliver outside of Rorya District.\n2. Women who deliver preterm, before they have exposure to all the interventions.'}, 'identificationModule': {'nctId': 'NCT03024905', 'acronym': 'EWH', 'briefTitle': 'Project to Use Community Health Workers to Reduce Maternal Deaths', 'organization': {'class': 'OTHER', 'fullName': 'Bruyère Health Research Institute.'}, 'officialTitle': 'Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania', 'orgStudyIdInfo': {'id': '108026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Division 1', 'description': 'The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial.\n\nInterventions are behavioural and device:\n\nBehavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.\n\nDevice: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).', 'interventionNames': ['Behavioral: Village meeting and travel vouchers', 'Device: Birth kit with misoprostol']}, {'type': 'EXPERIMENTAL', 'label': 'Division 2', 'description': 'The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial.\n\nInterventions are behavioural and device:\n\nBehavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.\n\nDevice: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).', 'interventionNames': ['Behavioral: Village meeting and travel vouchers', 'Device: Birth kit with misoprostol']}, {'type': 'EXPERIMENTAL', 'label': 'Division 3', 'description': 'The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial.\n\nInterventions are behavioural and device:\n\nBehavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.\n\nDevice: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).', 'interventionNames': ['Behavioral: Village meeting and travel vouchers', 'Device: Birth kit with misoprostol']}, {'type': 'EXPERIMENTAL', 'label': 'Division 4', 'description': 'The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial.\n\nnterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.\n\nDevice: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).', 'interventionNames': ['Behavioral: Village meeting and travel vouchers', 'Device: Birth kit with misoprostol']}], 'interventions': [{'name': 'Village meeting and travel vouchers', 'type': 'BEHAVIORAL', 'description': 'The interventions are:\n\n1. Village meetings by community health workers to educate women and their families about safe birthing.\n2. Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.', 'armGroupLabels': ['Division 1', 'Division 2', 'Division 3', 'Division 4']}, {'name': 'Birth kit with misoprostol', 'type': 'DEVICE', 'description': 'Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).', 'armGroupLabels': ['Division 1', 'Division 2', 'Division 3', 'Division 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shirati, Rorya District', 'state': 'Mara', 'country': 'Tanzania', 'facility': 'Shirati District Hospital Research Office', 'geoPoint': {'lat': -1.13333, 'lon': 33.98333}}], 'overallOfficials': [{'name': 'Bwire Chirangi, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Shirati KMT Hospital'}, {'name': 'Gail C Webber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bruyère Health Research Institute.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bruyère Health Research Institute.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, {'name': 'Shirati KMT Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Scientist', 'investigatorFullName': 'Gail Webber', 'investigatorAffiliation': 'Bruyère Health Research Institute.'}}}}