Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 11:43 PM
Study NCT ID:
NCT03135158
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Shock Index and Severity of Postpartum Blood Loss
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between blood loss and shock index', 'timeFrame': 'Within 1 hour postpartum', 'description': 'Correlate shock index, heart rate, and blood pressure measurements with blood loss levels at 15, 30, 45 \\& 60 minutes'}], 'secondaryOutcomes': [{'measure': 'Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml', 'timeFrame': 'Up to two hours postpartum', 'description': 'Proportions with ≥ 500 ml and ≥ 1000 ml blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops'}, {'measure': 'Median blood loss in the postpartum and interquartile range', 'timeFrame': 'Up to two hours postpartum', 'description': 'Blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops'}, {'measure': 'Percentage of women who received treatment to control bleeding', 'timeFrame': 'Up to two hours postpartum'}, {'measure': 'Average change in Hb measured before and after delivery', 'timeFrame': 'Pre-delivery and at least 24 hours postpartum', 'description': 'Among women receiving treatment to control postpartum hemorrhage'}, {'measure': 'Percentage of women with complications', 'timeFrame': 'Through study completion, an average of 24-48 hours postpartum', 'description': 'Among women receiving treatment to control postpartum hemorrhage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women presenting for vaginal delivery will be invited to participate', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receive care for vaginal delivery\n\nExclusion Criteria:\n\n* Scheduled or transferred for cesarean section\n* Cannot give informed consent\n* Are not willing and/or cannot answer the questionnaire on their background'}, 'identificationModule': {'nctId': 'NCT03135158', 'briefTitle': 'The Association Between Shock Index and Severity of Postpartum Blood Loss', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study', 'orgStudyIdInfo': {'id': '3009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women in labor', 'description': 'All participants who have a vaginal delivery', 'interventionNames': ['Other: Exposure to vaginal delivery']}], 'interventions': [{'name': 'Exposure to vaginal delivery', 'type': 'OTHER', 'description': 'Women who have vaginal births are observed for a minimum of 1 hour postpartum', 'armGroupLabels': ['Women in labor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cali', 'country': 'Colombia', 'facility': 'Fundación Valle del Lili', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Jill Durocher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Ilana Dzuba, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Clinica Valle del Lili', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}