Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01608958
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2012-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum 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': 'D006470', 'term': '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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 653}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean blood loss (ml)', 'timeFrame': 'minimum of 1 hour after delivery of baby'}], 'secondaryOutcomes': [{'measure': 'Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml', 'timeFrame': 'minimum of 1 hour after delivery of baby'}, {'measure': 'Change in hemoglobin from pre-delivery to postpartum', 'timeFrame': '12-24 hours after delivery', 'description': 'Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.'}, {'measure': 'Time to placental delivery', 'timeFrame': 'minimum of 1 hour after delivery of baby'}, {'measure': 'Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy', 'timeFrame': 'minimum of 1 hour after delivery of baby'}, {'measure': 'Side effects 1 hour postpartum', 'timeFrame': '1 hour postpartum'}, {'measure': 'Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward', 'timeFrame': 'arrival to labor ward'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postpartum hemorrhage', 'Oxytocin', 'Third stage of labor', 'Hemoglobin', 'Prevention', 'Intravenous', 'Intramuscular'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '33169839', 'type': 'DERIVED', 'citation': 'Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.', 'detailedDescription': 'The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women who present in active labor for a live birth at the study hospital will be considered for participation in the study\n\nExclusion Criteria: Women who are:\n\n* Planned or transferred for delivery via Cesarean section\n* Not delivering a live birth\n* Unable to provide informed consent due to mental impairment, distress during labor or other reason\n* Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.'}, 'identificationModule': {'nctId': 'NCT01608958', 'briefTitle': 'IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage', 'orgStudyIdInfo': {'id': '3000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV infusion', 'description': 'Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IM Injection', 'description': 'Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': '10 IU oxytocin in 500 ml infusion', 'armGroupLabels': ['IV infusion']}, {'name': 'Oxytocin', 'type': 'DRUG', 'description': '10 IU oxytocin IM injection', 'armGroupLabels': ['IM Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quito', 'country': 'Ecuador', 'facility': 'Hospital Gineco-Obstétrico Isidro Ayora', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Huong Vuong Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Ilana Dzuba, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Jill Durocher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Jennifer Blum, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Research and Consultancy in Reproductive Health', 'class': 'OTHER'}, {'name': 'Huong Vuong Hospital', 'class': 'UNKNOWN'}, {'name': "MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}