Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01241318
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2010-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zambia Chlorhexidine Application Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D000891', 'term': 'Anti-Infective Agents, Local'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ksemrau@ariadnelabs.org', 'phone': '6177805311', 'title': 'Katherine Semrau (Epidemiologist, co-PI)', 'organization': 'Ariadne Labs|BWH & HSPH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Only 89% (37 856 of 42 570) of the target sample size was attained. When we completed a post-hoc power calculation with the obtained sample size and observed Neonatal Mortality Rate (NMR), we had 80% power to detect a 28% reduction in NMR.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected during the 1 month follow up period past delivery.', 'description': 'Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.', 'eventGroups': [{'id': 'EG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.", 'otherNumAtRisk': 18510, 'deathsNumAtRisk': 18510, 'otherNumAffected': 9, 'seriousNumAtRisk': 18510, 'deathsNumAffected': 282, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.", 'otherNumAtRisk': 19346, 'deathsNumAtRisk': 19346, 'otherNumAffected': 0, 'seriousNumAtRisk': 19346, 'deathsNumAffected': 263, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chlorhexidine-related adverse events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18510, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19346, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine ocular exposure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19346, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause Neonatal Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18450', 'groupId': 'OG000'}, {'value': '19308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."}, {'id': 'OG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."}], 'classes': [{'title': 'Neonatal mortality', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}]}, {'title': 'Survived to day 28', 'categories': [{'measurements': [{'value': '18168', 'groupId': 'OG000'}, {'value': '19045', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.44', 'estimateComment': 'The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-partum', 'description': 'All-cause neonatal mortality based on vital status at 28 days post-partum', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18424', 'groupId': 'OG000'}, {'value': '19266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."}, {'id': 'OG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."}], 'classes': [{'title': 'Neonatal mortality', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}, {'title': 'Survived to day 28', 'categories': [{'measurements': [{'value': '18224', 'groupId': 'OG000'}, {'value': '19080', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.47', 'estimateComment': 'Generalized estimating equation models adjusting for cluster-randomized design were used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-partum', 'description': 'All-cause mortality by day 28 of life among newborns who survive at least the first day of life', 'unitOfMeasure': 'neonates who survived first 24 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'All liveborn neonates who survived the first 24 hours after delivery'}, {'type': 'SECONDARY', 'title': 'Incidence of Omphalitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18510', 'groupId': 'OG000'}, {'value': '19346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."}, {'id': 'OG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."}], 'classes': [{'title': 'Omphalitis', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'No omphalitis', 'categories': [{'measurements': [{'value': '18428', 'groupId': 'OG000'}, {'value': '19228', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.13', 'estimateComment': 'Generalized estimating equation models adjusting for cluster-randomized design were used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days postpartum', 'description': 'Omphalitis, or umbilical cord infection, defined as:\n\n* presence of umbilical cord pus and mild, moderate or severe redness\n* moderate or severe redness without the presence of umbilical cord pus', 'unitOfMeasure': 'neonates', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Place of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18510', 'groupId': 'OG000'}, {'value': '19346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."}, {'id': 'OG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."}], 'classes': [{'categories': [{'title': 'Home Delivery', 'measurements': [{'value': '6509', 'groupId': 'OG000'}, {'value': '6682', 'groupId': 'OG001'}]}, {'title': 'Facility Delivery', 'measurements': [{'value': '11456', 'groupId': 'OG000'}, {'value': '12204', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days postpartum', 'description': 'The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Factors Influencing Delivery Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23815', 'groupId': 'OG000'}, {'value': '13255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility Delivery', 'description': 'Women who enrolled in ZamCAT study and delivered at a facility'}, {'id': 'OG001', 'title': 'Home Delivery', 'description': 'Women who enrolled in ZamCAT study and delivered at home'}], 'classes': [{'title': 'Same Location as Prior Delivery', 'categories': [{'measurements': [{'value': '3198', 'groupId': 'OG000'}, {'value': '2082', 'groupId': 'OG001'}]}]}, {'title': 'Need for Skilled Attendance12991', 'categories': [{'measurements': [{'value': '12991', 'groupId': 'OG000'}, {'value': '5693', 'groupId': 'OG001'}]}]}, {'title': 'Financial Constraints', 'categories': [{'measurements': [{'value': '1823', 'groupId': 'OG000'}, {'value': '1249', 'groupId': 'OG001'}]}]}, {'title': 'Physical Distance', 'categories': [{'measurements': [{'value': '6345', 'groupId': 'OG000'}, {'value': '3930', 'groupId': 'OG001'}]}]}, {'title': 'Relationship with Provider', 'categories': [{'measurements': [{'value': '572', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}]}]}, {'title': 'Family/Social Expectations', 'categories': [{'measurements': [{'value': '1255', 'groupId': 'OG000'}, {'value': '990', 'groupId': 'OG001'}]}]}, {'title': 'Safety for Mother/Baby', 'categories': [{'measurements': [{'value': '14129', 'groupId': 'OG000'}, {'value': '5911', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1480', 'groupId': 'OG000'}, {'value': '803', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1364', 'groupId': 'OG000'}, {'value': '770', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days postpartum', 'description': 'Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Women enrolled in the ZamCAT study and delivery location known. Please note these are different denominators reported as this analysis is not based on intervention randomization, but rather an analysis focused on women's location of childbirth. Therefore, the number of women included in this analysis is based on a subset of all women enrolled."}, {'type': 'SECONDARY', 'title': 'Health Facility Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39679', 'groupId': 'OG000'}]}, {'units': 'Health facilities', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Health Facilities & Hospitals', 'description': '90 health facilities and 10 district hospitals were included in the main chlorhexidine trial. A survey was completed to assess availability of emergency obstetric care.'}], 'classes': [{'title': 'Basic emergency obstetrical and newborn care', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'No basic emergency obstetrical and newborn care', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after study initiation', 'description': 'Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).', 'unitOfMeasure': 'Health facilities', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Health facilities', 'denomUnitsSelected': 'Health facilities', 'populationDescription': 'Health facilities'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."}, {'id': 'FG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Women enrolled', 'groupId': 'FG000', 'numSubjects': '19629'}, {'comment': 'Women enrolled', 'groupId': 'FG001', 'numSubjects': '20050'}]}, {'type': 'Liveborn Infant', 'achievements': [{'comment': 'Infants', 'groupId': 'FG000', 'numSubjects': '18510'}, {'comment': 'Infants', 'groupId': 'FG001', 'numSubjects': '19346'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Infants', 'groupId': 'FG000', 'numSubjects': '18450'}, {'comment': 'Infants', 'groupId': 'FG001', 'numSubjects': '19308'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1179'}, {'groupId': 'FG001', 'numSubjects': '742'}]}], 'dropWithdraws': [{'type': 'Woman: false pregnancies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Woman: miscarriage/abortion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '740'}, {'groupId': 'FG001', 'numSubjects': '455'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrew/Lost to Follow after delivery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Woman: Stillborn infant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '146'}]}]}], 'recruitmentDetails': 'In the 90 clusters (i.e. government-run health facilities), pregnant women who met eligibility criteria attending antenatal care were offered enrollment. Recruitment started February 15, 2011 and ended January 30, 2013.', 'preAssignmentDetails': 'Mothers were enrolled in the study while pregnant and infants were enrolled after delivery; thus the total protocol enrollment is women + infants. Study reporting is completed at the woman level and thus the total enrolled is listed at the woman level in the outcomes tables.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19629', 'groupId': 'BG000'}, {'value': '20050', 'groupId': 'BG001'}, {'value': '39679', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlorhexidine Cord Care', 'description': "Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.\n\nChlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."}, {'id': 'BG001', 'title': 'Dry Cord Care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nDry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<20 years', 'categories': [{'measurements': [{'value': '4671', 'groupId': 'BG000'}, {'value': '4580', 'groupId': 'BG001'}, {'value': '9251', 'groupId': 'BG002'}]}]}, {'title': '20-35 years', 'categories': [{'measurements': [{'value': '12772', 'groupId': 'BG000'}, {'value': '13122', 'groupId': 'BG001'}, {'value': '25894', 'groupId': 'BG002'}]}]}, {'title': '>35 years', 'categories': [{'measurements': [{'value': '2012', 'groupId': 'BG000'}, {'value': '2194', 'groupId': 'BG001'}, {'value': '4206', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not recorded)', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19629', 'groupId': 'BG000'}, {'value': '20050', 'groupId': 'BG001'}, {'value': '39679', '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/Ethnicity, Customized', 'classes': [{'title': 'Tonga', 'categories': [{'measurements': [{'value': '17003', 'groupId': 'BG000'}, {'value': '17650', 'groupId': 'BG001'}, {'value': '34653', 'groupId': 'BG002'}]}]}, {'title': 'Ila', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}, {'title': 'Lozi', 'categories': [{'measurements': [{'value': '786', 'groupId': 'BG000'}, {'value': '795', 'groupId': 'BG001'}, {'value': '1581', 'groupId': 'BG002'}]}]}, {'title': 'Nyanja', 'categories': [{'measurements': [{'value': '525', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}]}, {'title': 'Bemba', 'categories': [{'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '433', 'groupId': 'BG001'}, {'value': '846', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '629', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '1110', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not recorded)', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Zambia', 'categories': [{'measurements': [{'value': '19629', 'groupId': 'BG000'}, {'value': '20050', 'groupId': 'BG001'}, {'value': '39679', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maternal Education', 'classes': [{'title': 'No eduction', 'categories': [{'measurements': [{'value': '1936', 'groupId': 'BG000'}, {'value': '1958', 'groupId': 'BG001'}, {'value': '3894', 'groupId': 'BG002'}]}]}, {'title': 'Lower Primary', 'categories': [{'measurements': [{'value': '2293', 'groupId': 'BG000'}, {'value': '2563', 'groupId': 'BG001'}, {'value': '4856', 'groupId': 'BG002'}]}]}, {'title': 'Upper Primary', 'categories': [{'measurements': [{'value': '7731', 'groupId': 'BG000'}, {'value': '7874', 'groupId': 'BG001'}, {'value': '15605', 'groupId': 'BG002'}]}]}, {'title': 'Junior Secondary', 'categories': [{'measurements': [{'value': '5422', 'groupId': 'BG000'}, {'value': '5499', 'groupId': 'BG001'}, {'value': '10921', 'groupId': 'BG002'}]}]}, {'title': 'Upper Secondary', 'categories': [{'measurements': [{'value': '1895', 'groupId': 'BG000'}, {'value': '1840', 'groupId': 'BG001'}, {'value': '3735', 'groupId': 'BG002'}]}]}, {'title': '>Upper Secondary', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}, {'title': 'Do not know', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not recorded)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Single', 'categories': [{'measurements': [{'value': '3021', 'groupId': 'BG000'}, {'value': '3133', 'groupId': 'BG001'}, {'value': '6154', 'groupId': 'BG002'}]}]}, {'title': 'Married', 'categories': [{'measurements': [{'value': '16107', 'groupId': 'BG000'}, {'value': '16499', 'groupId': 'BG001'}, {'value': '32606', 'groupId': 'BG002'}]}]}, {'title': 'Separated, divorced or widowed', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}]}, {'title': 'Cohabiting', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not recorded)', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maternal literacy', 'classes': [{'title': 'Not at all', 'categories': [{'measurements': [{'value': '5037', 'groupId': 'BG000'}, {'value': '5491', 'groupId': 'BG001'}, {'value': '10528', 'groupId': 'BG002'}]}]}, {'title': 'A bit', 'categories': [{'measurements': [{'value': '8835', 'groupId': 'BG000'}, {'value': '9516', 'groupId': 'BG001'}, {'value': '18351', 'groupId': 'BG002'}]}]}, {'title': 'Very well', 'categories': [{'measurements': [{'value': '5492', 'groupId': 'BG000'}, {'value': '4835', 'groupId': 'BG001'}, {'value': '10327', 'groupId': 'BG002'}]}]}, {'title': 'No response from mother', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not recorded)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '335', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Household water source', 'classes': [{'title': 'Household tap', 'categories': [{'measurements': [{'value': '1861', 'groupId': 'BG000'}, {'value': '1715', 'groupId': 'BG001'}, {'value': '3576', 'groupId': 'BG002'}]}]}, {'title': 'Community tap', 'categories': [{'measurements': [{'value': '1919', 'groupId': 'BG000'}, {'value': '1761', 'groupId': 'BG001'}, {'value': '3680', 'groupId': 'BG002'}]}]}, {'title': 'Other water source on own property', 'categories': [{'measurements': [{'value': '2295', 'groupId': 'BG000'}, {'value': '2403', 'groupId': 'BG001'}, {'value': '4698', 'groupId': 'BG002'}]}]}, {'title': 'Community well or river', 'categories': [{'measurements': [{'value': '13241', 'groupId': 'BG000'}, {'value': '13768', 'groupId': 'BG001'}, {'value': '27009', 'groupId': 'BG002'}]}]}, {'title': 'No answer from Mother', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}, {'title': 'Missing (Not recorded)', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pregnancies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gravida', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'deliveries', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational Age at enrollment', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '28.4', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Slept under mosquito bednet the previous night', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '11092', 'groupId': 'BG000'}, {'value': '11783', 'groupId': 'BG001'}, {'value': '22875', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '8310', 'groupId': 'BG000'}, {'value': '8075', 'groupId': 'BG001'}, {'value': '16385', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not recorded)', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Pregnant women attending health facilities for antenatal care'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-16', 'studyFirstSubmitDate': '2010-11-12', 'resultsFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-04', 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Neonatal Mortality', 'timeFrame': '28 days post-partum', 'description': 'All-cause neonatal mortality based on vital status at 28 days post-partum'}, {'measure': 'All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life', 'timeFrame': '28 days post-partum', 'description': 'All-cause mortality by day 28 of life among newborns who survive at least the first day of life'}], 'secondaryOutcomes': [{'measure': 'Incidence of Omphalitis', 'timeFrame': '28 days postpartum', 'description': 'Omphalitis, or umbilical cord infection, defined as:\n\n* presence of umbilical cord pus and mild, moderate or severe redness\n* moderate or severe redness without the presence of umbilical cord pus'}, {'measure': 'Place of Delivery', 'timeFrame': '28 days postpartum', 'description': 'The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.'}, {'measure': 'Factors Influencing Delivery Location', 'timeFrame': '28 days postpartum', 'description': 'Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)'}, {'measure': 'Health Facility Characteristics', 'timeFrame': '12 months after study initiation', 'description': 'Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neonate', 'omphalitis', 'neonatal mortality', 'maternal health', 'umbilical cord infection'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '19845951', 'type': 'BACKGROUND', 'citation': 'Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67.'}, {'pmid': '16546539', 'type': 'BACKGROUND', 'citation': 'Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. doi: 10.1016/S0140-6736(06)68381-5.'}, {'pmid': '22322124', 'type': 'BACKGROUND', 'citation': 'Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.'}, {'pmid': '22322126', 'type': 'BACKGROUND', 'citation': 'Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.'}, {'pmid': '35256443', 'type': 'DERIVED', 'citation': 'Solomon H, Henry EG, Herlihy J, Yeboah-Antwi K, Biemba G, Musokotwane K, Bhutta A, Hamer DH, Semrau KEA. Intended versus actual delivery location and factors associated with change in delivery location among pregnant women in Southern Province, Zambia: a prespecified secondary observational analysis of the ZamCAT. BMJ Open. 2022 Mar 7;12(3):e055288. doi: 10.1136/bmjopen-2021-055288.'}, {'pmid': '33951036', 'type': 'DERIVED', 'citation': 'Park JH, Hamer DH, Mbewe R, Scott NA, Herlihy JM, Yeboah-Antwi K, Semrau KEA. Components of clean delivery kits and newborn mortality in the Zambia Chlorhexidine Application Trial (ZamCAT): An observational study. PLoS Med. 2021 May 5;18(5):e1003610. doi: 10.1371/journal.pmed.1003610. eCollection 2021 May.'}, {'pmid': '28558800', 'type': 'DERIVED', 'citation': 'Henry EG, Semrau K, Hamer DH, Vian T, Nambao M, Mataka K, Scott NA. The influence of quality maternity waiting homes on utilization of facilities for delivery in rural Zambia. Reprod Health. 2017 May 30;14(1):68. doi: 10.1186/s12978-017-0328-z.'}, {'pmid': '27693439', 'type': 'DERIVED', 'citation': 'Semrau KEA, Herlihy J, Grogan C, Musokotwane K, Yeboah-Antwi K, Mbewe R, Banda B, Mpamba C, Hamomba F, Pilingana P, Zulu A, Chanda-Kapata P, Biemba G, Thea DM, MacLeod WB, Simon JL, Hamer DH. Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial. Lancet Glob Health. 2016 Nov;4(11):e827-e836. doi: 10.1016/S2214-109X(16)30215-7. Epub 2016 Sep 29.'}, {'pmid': '25646254', 'type': 'DERIVED', 'citation': 'Hamer DH, Herlihy JM, Musokotwane K, Banda B, Mpamba C, Mwangelwa B, Pilingana P, Thea DM, Simon JL, Yeboah-Antwi K, Grogan C, Semrau KE. Engagement of the community, traditional leaders, and public health system in the design and implementation of a large community-based, cluster-randomized trial of umbilical cord care in Zambia. Am J Trop Med Hyg. 2015 Mar;92(3):666-72. doi: 10.4269/ajtmh.14-0218. Epub 2015 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.', 'detailedDescription': 'The primary goals of the Zambia Chlorhexidine Application Trial (ZamCAT) are to assess whether daily 4% chlorhexidine cord cleansing is more effective than dry cord care for the prevention of neonatal deaths and omphalitis (umbilical cord infection) in Southern Province, Zambia. Secondary goals are to 1) compare where pregnant women plan to deliver and where they actually deliver, and 2) to describe the health services network available to pregnant and postpartum women in case of serious illness among the women and their newborn infants.\n\nClusters consisting of individual health centers and their respective catchment areas will be assigned to one of two arms. In the intervention clusters, mothers will apply 4% chlorhexidine to their infants daily until 3 days after the cord completely separates. Mothers in the control clusters will use dry cord care as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.\n\nIn order to achieve the 4th Millennium Development Goal of reducing child mortality by two-thirds, simple, inexpensive, and scalable interventions are required. If the use of a 4% chlorhexidine umbilical cord wash effectively reduces neonatal mortality, this will be a low-cost intervention that can be easily translated from a research project into a program for countrywide implementation in Zambia. These results will also add to the limited evidence base about the effectiveness of interventions for reduction of neonatal mortality in sub-Saharan Africa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'pregnant women so only women 15 and older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in the 2nd or 3rd trimester\n* Age 15 years and above\n* Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum\n* Willingness to provide cord care as per the protocol of their cluster\n* Willingness to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant women who are not willing to provide cord care as per the protocol of their cluster\n* Pregnant women who are not willing to provide informed consent\n* Pregnant women in the 1st trimester\n* Pregnant women under age 15 years'}, 'identificationModule': {'nctId': 'NCT01241318', 'acronym': 'ZamCAT', 'briefTitle': 'Zambia Chlorhexidine Application Trial', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia', 'orgStudyIdInfo': {'id': 'H-29647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine cord care', 'description': 'Mothers located in health facility catchment areas assigned to this arm will apply Chlorhexidine gluconate (4%) to their infants daily until three days after the cord completely separates. Bottles of chlorhexidine is provided to women during antenatal care.', 'interventionNames': ['Drug: Chlorhexidine gluconate (4%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dry cord care', 'description': "Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.", 'interventionNames': ['Procedure: Dry cord care']}], 'interventions': [{'name': 'Chlorhexidine gluconate (4%)', 'type': 'DRUG', 'otherNames': ['topical antiseptic'], 'description': "Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.", 'armGroupLabels': ['Chlorhexidine cord care']}, {'name': 'Dry cord care', 'type': 'PROCEDURE', 'description': "Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.", 'armGroupLabels': ['Dry cord care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Choma', 'state': 'Southern Province', 'country': 'Zambia', 'facility': 'Facilities throughout Southern Province', 'geoPoint': {'lat': -16.80889, 'lon': 26.9875}}], 'overallOfficials': [{'name': 'Davidson H Hamer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University Center for Global Health and Development'}, {'name': 'Katherine Semrau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University Center for Global Health and Development'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Ministry of Health, Zambia', 'class': 'OTHER_GOV'}, {'name': 'Zambia Center for Applied Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}