Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-04-16 @ 5:36 PM
Study NCT ID:
NCT01865656
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D001238', 'term': 'Asphyxia Neonatorum'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15018}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appropriate management of direct obstetric and perinatal complications', 'timeFrame': 'Month 18 of the project', 'description': 'Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the intervention', 'timeFrame': 'Month 18 of the project', 'description': 'We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.'}, {'measure': 'Acceptability of the intervention', 'timeFrame': 'Month 18 of the project', 'description': 'Using in-depth interviews with providers, we will assess the acceptability of the interventions.'}, {'measure': 'Self-efficacy of health care personnel to manage direct obstetric and neonatal complications', 'timeFrame': 'Month 18 of the project', 'description': 'Providers will be assessed on self-efficacy pre and post intervention'}, {'measure': 'Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications', 'timeFrame': 'Month 18 of the project'}, {'measure': 'Case-fatality rates', 'timeFrame': 'Month 18 of the project', 'description': 'Using data from obstetric and newborn case sheets we will assess case-fatality rates'}, {'measure': 'Timeliness and appropriateness of referral', 'timeFrame': 'Month 18 of the project'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['provider skill and self-efficacy', 'Appropriate and timely referral for obstetric emergencies', 'Intervention feasibility and acceptability'], 'conditions': ['Obstetric and Perinatal Complications', 'Postpartum Hemorrhage', 'Preeclampsia/Eclampsia', 'Obstructed/Prolonged Labor', 'Sepsis', 'Birth Asphyxia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of EmONC skills and drills intervention.', 'detailedDescription': 'The aim of this intervention is to improve the quality of care for institutional births with a special focus on improving the quality of Emergency Obstetric and Newborn Care (EmONC). This intervention will focus on improving the skills and practices of providers and through the improvement of referral networks, ensure timely and appropriate management of complications.\n\nThe specific objectives include:\n\n1. Evaluate the effectiveness of an FRU-level Basic and EmONC Skills and Drills intervention combined with the existing primary health centre (PHC) based nurse mentoring intervention in improving appropriate diagnosis and management of obstetric and perinatal complications.\n2. Assess the additional benefit of the EmONC Skills and drills intervention at FRUs in terms of improvement of obstetric and perinatal outcomes compared to the PHC-level intervention alone.\n3. Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls.\n4. Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll women age who are referred or admitted directly to the first referral unit for a delivery or with a complication Staff working in the First Referral Units\n\nExclusion Criteria:\n\nno specific exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01865656', 'briefTitle': 'A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka', 'orgStudyIdInfo': {'id': 'MHTF IR India'}, 'secondaryIdInfos': [{'id': 'REF/2013/05/005058', 'type': 'REGISTRY', 'domain': 'Clinical Trials Registry- India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '4 intervention first referral units', 'description': 'A Quasi-experimental intervention/control trial will be implemented to assess the impact of the following interventions on the outcome measures in a cluster of 4 intervention sites relative to a matched cluster of 4 control sites:\n\nRefresher/simulation training to improve provider skills/knowledge Implementation of Emergency Obstetric Drills Revised Case sheets(for data collection and therefore part of both control and intervention sites), Mentoring and Supportive supervision, and Referral Strengthening', 'interventionNames': ['Other: Skills training', 'Other: Emergency obstetric drills', 'Other: Revised Case Sheets', 'Other: Supportive supervision', 'Other: Referral strengthening']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm'}], 'interventions': [{'name': 'Skills training', 'type': 'OTHER', 'description': 'Refresher training on Basic Emergency Obstetric and Newborn care', 'armGroupLabels': ['4 intervention first referral units']}, {'name': 'Emergency obstetric drills', 'type': 'OTHER', 'description': 'Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia', 'armGroupLabels': ['4 intervention first referral units']}, {'name': 'Revised Case Sheets', 'type': 'OTHER', 'description': 'Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns', 'armGroupLabels': ['4 intervention first referral units']}, {'name': 'Supportive supervision', 'type': 'OTHER', 'description': 'Quarterly supportive supervision visits each of the intervention first referral units.', 'armGroupLabels': ['4 intervention first referral units']}, {'name': 'Referral strengthening', 'type': 'OTHER', 'description': 'To support referral systems that ensure timely and appropriate treatment for obstetric emergencies', 'armGroupLabels': ['4 intervention first referral units']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Beena Verghese, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Research Institute, Public Health Foundation of India"}, {'name': 'Prem Mony, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Research Institute, Bangalore"}, {'name': 'Krishnamurthy Jeyanna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karnataka Health Promotion Trust'}, {'name': 'Ana Langer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Fernando Althabe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Clinical Effectiveness and Health Policy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': "St. John's Research Institute", 'class': 'OTHER'}, {'name': 'Maternal Health Task Force', 'class': 'UNKNOWN'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Karnataka Health Promotion Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Women and Health Initiative', 'investigatorFullName': 'Ana Langer', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}