Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-22 @ 5:44 PM
Study NCT ID:
NCT02954068
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2016-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Versus IM Administration of Oxytocin for Postpartum Bleeding
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 543}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of blood loss (mL)', 'timeFrame': '1 hour postpartum'}, {'measure': 'Proportion of women who had postpartum blood loss ≥500 ml', 'timeFrame': '1 hour postpartum'}], 'secondaryOutcomes': [{'measure': 'Proportion of women who had postpartum blood loss ≥1000 ml', 'timeFrame': '1 hour postpartum'}, {'measure': 'Average change in hemoglobin level', 'timeFrame': 'pre-delivery and at least 24 hours postpartum'}, {'measure': 'Average time required until expulsion of the placenta', 'timeFrame': '1 hour postpartum'}, {'measure': 'Proportion who needed additional Interventions', 'timeFrame': 'Through study completion, an average of 24-48 hours postpartum'}, {'measure': 'Side effects', 'timeFrame': '1 hour postpartum'}, {'measure': 'Blood pressure', 'timeFrame': '15, 30, 45 and 60 minutes postpartum'}, {'measure': 'Heart rate', 'timeFrame': '15, 30, 45 and 60 minutes postpartum'}]}, 'conditionsModule': {'keywords': ['Oxytocin'], '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': 'This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* She is present to give birth to a live fetus\n* Vaginal delivery\n* Willing to participate in the study\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Scheduled for a cesarean\n* Reject the placement of an IV during labor (for intravenous infusion)\n* Cannot give informed consent for any reason\n* Not willing and / or cannot answer questions about background'}, 'identificationModule': {'nctId': 'NCT02954068', 'briefTitle': 'IV Versus IM Administration of Oxytocin for Postpartum Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study', 'orgStudyIdInfo': {'id': '3008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV Infusion', 'description': 'Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU', 'interventionNames': ['Drug: IV Oxytocin + IM placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IM administration', 'description': 'Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml', 'interventionNames': ['Drug: IM Oxytocin + IV placebo']}], 'interventions': [{'name': 'IV Oxytocin + IM placebo', 'type': 'DRUG', 'armGroupLabels': ['IV Infusion']}, {'name': 'IM Oxytocin + IV placebo', 'type': 'DRUG', 'armGroupLabels': ['IM administration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Hospital J.R. Vidal', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Ilana Dzuba, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Guillermo Carroli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Rosarino de Estudios Perinatales (CREP)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Rosarino de Estudios Perinatales (CREP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}