Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-06 @ 12:49 PM
Study NCT ID:
NCT02605369
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2015-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066087', 'term': 'Perinatal Death'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1877}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-07', 'studyFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2015-11-12', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Low birthweight', 'timeFrame': 'Up-to 48 hours after birth', 'description': 'Proportion of infants with a birthweight =\\< 2500gms'}, {'measure': 'Preterm birth', 'timeFrame': '7 days postpartum', 'description': 'Proportion of infants born at less than 37 completed weeks of gestation measured by the New Ballad Score'}, {'measure': 'Neonatal hypoglycemia', 'timeFrame': 'Up-to 7 days after birth', 'description': 'Proportion of infants with random blood glucose less than 47mg/dl'}], 'primaryOutcomes': [{'measure': 'Facility based birth', 'timeFrame': 'Day 1', 'description': 'Delivery at a health facility'}], 'secondaryOutcomes': [{'measure': 'Neonatal death', 'timeFrame': 'Day 28', 'description': 'Death within the first month of life'}, {'measure': 'Timely initiation of breastfeeding', 'timeFrame': 'Up-to one hour after birth', 'description': 'Initiation of breastfeeding with the first hour after birth'}, {'measure': 'Severe illness', 'timeFrame': 'Day 28', 'description': 'Severe illness within the first month of life'}, {'measure': 'The percent of newborns attended by a health care pro-vider during the first 48 hours following birth', 'timeFrame': 'Up-to 48 hours after birth', 'description': 'Proportion of babies seen by a health care work in the first 48 hours after birth'}, {'measure': 'The percent of newborns attended by a health care pro-vider during the first 7 days following birth', 'timeFrame': '1 week', 'description': 'Proportion of babies seen by a health care work in the first one week after birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Facility births'], 'conditions': ['Neonatal Death', 'Preterm Birth', 'Low Birthweight', 'Neonatal Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '38326267', 'type': 'DERIVED', 'citation': 'Nankabirwa V, Mukunya D, Ndeezi G, Odongkara B, Arach AA, Achora V, Mugenyi L, Sebit MB, Wandabwa JN, Waako P, Tylleskar T, Tumwine JK. Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda. BMJ Open. 2024 Feb 7;14(2):e070798. doi: 10.1136/bmjopen-2022-070798.'}, {'pmid': '33574146', 'type': 'DERIVED', 'citation': 'Mukunya D, Tumwine JK, Nankabirwa V, Odongkara B, Tongun JB, Arach AA, Tumuhamye J, Napyo A, Zalwango V, Achora V, Musaba MW, Ndeezi G, Tylleskar T. Neonatal hypothermia in Northern Uganda: a community-based cross-sectional study. BMJ Open. 2021 Feb 11;11(2):e041723. doi: 10.1136/bmjopen-2020-041723.'}]}, 'descriptionModule': {'briefSummary': 'Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women at 28 or more weeks of gestation\n* Residence in the selected clusters\n* Pregnant women under 18 years of age will be included since they are considered as emancipated minors in Uganda\n\nExclusion Criteria:\n\n* Intention to move from the study area within one year\n* Psychiatric ailments that may inhibit the informed consent process'}, 'identificationModule': {'nctId': 'NCT02605369', 'briefTitle': 'SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan', 'orgStudyIdInfo': {'id': '2015-121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm: An integrated package', 'description': 'Pregnant women in the intervention clusters will receive an integrated package consisting of peer support for facility based births by pregnancy buddies, mama kits and mobile phone messages. These components will all aim at mitigating the three delays and increasing the proportion of facility based births.', 'interventionNames': ['Behavioral: Intervention arm: An integrated package']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm: Standard of care', 'description': 'Pregnant women in the control clusters will continue to receive the standard of care for pregnant women according to Ugandan Ministry of Health guidelines'}], 'interventions': [{'name': 'Intervention arm: An integrated package', 'type': 'BEHAVIORAL', 'description': 'See description in previous column', 'armGroupLabels': ['Intervention arm: An integrated package']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lira', 'country': 'Uganda', 'facility': 'Lira District', 'geoPoint': {'lat': 2.2499, 'lon': 32.89985}}], 'overallOfficials': [{'name': 'Victoria Nankabirwa, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University'}, {'name': 'James K Tumwine, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}, {'name': 'Grace Ndeezi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere Univeristy'}, {'name': 'Thorkild Tylleskar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}, {'name': 'Paul Wako, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Busitema University'}, {'name': 'Joyce Kaducu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulu University'}, {'name': 'Jino Meleby', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Juba'}, {'name': 'Frederik Froen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian Institute of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The datasets used and/or analyzed during the current study will be available on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre For International Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}