Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01108302
Status:
WITHDRAWN
Last Update Posted:
2012-01-09
First Post:
2010-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PATH withdrew IRB approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-06', 'studyFirstSubmitDate': '2010-04-02', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postpartum hemorrhage', 'timeFrame': 'after delivery of baby', 'description': 'blood loss \\>=500 ml after delivery of the baby, as measured through a plastic calibrated drape.'}], 'secondaryOutcomes': [{'measure': 'Oxytocin use before delivery', 'timeFrame': 'labor and delivery', 'description': 'the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby'}, {'measure': 'stillbirth', 'timeFrame': 'pregnancy', 'description': 'stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby'}, {'measure': 'neonatal death', 'timeFrame': 'first month of life', 'description': 'neonatal death is defined as death of a live born infant prior to completion of 28 days'}, {'measure': 'need for neonatal resuscitation', 'timeFrame': '0-6 hours after birth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['uterotonic', 'oxytocin', 'randomized trial', 'India', 'community', 'hemorrhage'], 'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age \\>=28 wks at enrollment\n* anticipate spontaneous vaginal delivery\n* hemoglobin \\>=8 gm/dl\n* delivery at home, sub-center, or primary health center\n* delivery attended by Auxilliary Nurse Midwife\n\nExclusion Criteria:\n\n* previous caesarean-section\n* scheduled for caesarean-section\n* antepartum bleeding during current pregnancy\n* blood pressure \\>140mm of Hg systolic and \\>90mm of Hg diastolic\n* in active labor at time of recruitment\n* high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery'}, 'identificationModule': {'nctId': 'NCT01108302', 'briefTitle': "Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India", 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India', 'orgStudyIdInfo': {'id': 'GAT.1429-07882-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'PPH Treatment only', 'description': 'Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject'}, {'type': 'EXPERIMENTAL', 'label': 'Oxytocin in Uniject', 'description': 'Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery', 'interventionNames': ['Other: Oxytocin in Uniject']}], 'interventions': [{'name': 'Oxytocin in Uniject', 'type': 'OTHER', 'otherNames': ['Pitocin, Syntocinon'], 'description': '10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby', 'armGroupLabels': ['Oxytocin in Uniject']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belagavi', 'state': 'Karnataka', 'country': 'India', 'facility': "Jawaharlal Nehru Medical College Women's and Children's Health Research Unit", 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}], 'overallOfficials': [{'name': 'Cynthia Stanton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}, {'name': 'Shivaprasad Goudar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JN Medical College, Belgaum, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': "Jawaharlal Nehru Medical College Women's and Children's Health Research Unit", 'class': 'UNKNOWN'}, {'name': 'PATH', 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Cynthia Stanton', 'oldOrganization': 'Johns Hopkins Bloomberg School of Public Health'}}}}