Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-31 @ 9:00 PM
Study NCT ID:
NCT01994304
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment and Evaluation of the Safe Childbirth Checklist --Phase II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perinatal mortality', 'timeFrame': '18 months (Nov-2013 to May-2015)', 'description': 'This evaluation will independently estimate the effectiveness of the Safe Childbirth Checklist in reduce perinatal mortality by 15% in the intervention areas'}], 'secondaryOutcomes': [{'measure': 'Morbidity rates for infants and mothers', 'timeFrame': '18 months (Nov-2013 to May-2015)', 'description': 'We determine checklist-related morbidity rates for infants and mothers at the intervention facilities by observing the following:\n\n1. Level of Practices -use of partograph or recording of events; active management of third stage labor (AMTSL); early initiation of breast feeding; use of antihypertensives/magnesium sulphate for mothers and use of antibiotics for mother and neonate\n2. Levels of neonatal morbidity (low birth weight/prematurity, asphyxia, sepsis), maternal morbidity (Post partum haemorrhage, sepsis, eclampsia etc)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safe Childbirth Checklist', 'Intrapartum mortality, Quality of Institutional delivery care', 'Maternal & newborn care practices'], 'conditions': ['Intrapartum Mortality']}, 'referencesModule': {'references': [{'pmid': '30867935', 'type': 'DERIVED', 'citation': 'Varghese B, Copas A, Kumari S, Bandyopadhyay S, Sharma J, Saha S, Yadav V, Kumar S. Does the safe childbirth checklist (SCC) program save newborn lives? Evidence from a realistic quasi-experimental study, Rajasthan, India. Matern Health Neonatol Perinatol. 2019 Mar 1;5:3. doi: 10.1186/s40748-019-0098-4. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'http://www.phfi.org/', 'label': 'Related Info'}, {'url': 'http://ciff.org/impact/saving-babies-lives-rajasthan/', 'label': 'Saving lives through checklist'}]}, 'descriptionModule': {'briefSummary': 'PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design with data collection from 34 facilities across six intervention districts and four control districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in intrapartum mortality. Data on this was collected over a period of 17 months (November 2013 to April 2015).', 'detailedDescription': 'The Safe Childbirth Checklist (SCC), a tool that provides reminders and is a job aid to health care providers is a new maternal and newborn care intervention that is being implemented by the Government of Rajasthan with technical support from Jhpeigo. SCC is thus expected to improve the quality of delivery care practices and was implemented in Community Health Centres (CHCs) and District Hospitals (DHs) across seven districts in Rajasthan over a two-year time period (2013 to 2015). PHFI independently evaluated the effectiveness and cost-effectiveness of the SCC in preventing intrapartum (stillbirths and very early neonatal deaths within 3-days after births). Data on 137,000 births was collected over a period of 17 months (November 2013 to April 2015) from 34 facilities with sick newborn care centres (SNC).\n\nFacility records were main source of outcome data. Labor room provided data on stillbirths whereas information on very early neonatal deaths came from SNCs. All Data collection and management was done through software specifically developed for this purpose.\n\nFor a better understanding on how maternal and neonatal complications are diagnosed and managed at the facility, in-depth interviews were conducted with the service providers (specialists, physicians, labor room staff nurses, and pharmacists) from the District hospitals and CHCs. In addition, interviews focused on understanding the use, acceptability and feasibility of the SCC among various types of providers.\n\nCost of this intervention was estimated from a program perspective, and cost effectiveness in terms of cost per perinatal death prevented was calculated.\n\nPreliminary analysis has found that SCC is significantly associated with a 11% reduction in intrapartum deaths.\n\nPermission for this study and data collection has been obtained from the Department of Health and Family Welfare, Government of Rajasthan.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01994304', 'briefTitle': 'Assessment and Evaluation of the Safe Childbirth Checklist --Phase II', 'organization': {'class': 'OTHER', 'fullName': 'Public Health Foundation of India'}, 'officialTitle': 'Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India', 'orgStudyIdInfo': {'id': 'SCC--P2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No safe childbirth checklist', 'description': 'The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Safe Childbirth Checklist', 'description': 'The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu', 'interventionNames': ['Behavioral: SCC']}], 'interventions': [{'name': 'SCC', 'type': 'BEHAVIORAL', 'description': 'The intervention involves introducing and orienting health providers on the SCC, facilitating availability of a specific set of commodities and regular targeted supervision. These are expected to improve adherence to life saving interventions immediately before, during and after birth, and reduce intrapartum mortality (still births and very early neonatal deaths).', 'armGroupLabels': ['Safe Childbirth Checklist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'New Delhi', 'country': 'India', 'facility': 'Public Health Foundation of India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Beena Varghese, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health Foundation of India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health Foundation of India', 'class': 'OTHER'}, 'collaborators': [{'name': 'UBS Optimus Foundation', 'class': 'OTHER'}, {'name': "The Children's Investment Fund Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sr. Health Economist and Additional Professor', 'investigatorFullName': 'Dr. Beena Varghese', 'investigatorAffiliation': 'Public Health Foundation of India'}}}}