Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT03432767
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries
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': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-13', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shock index values', 'timeFrame': '2 hours', 'description': 'Calculated shock index (heart rate/systolic blood pressure) every 10 minutes from delivery until 2 hours postpartum.'}, {'measure': 'Hemoglobin values', 'timeFrame': '2 hours', 'description': 'Spectrophotometric hemoglobin values from a non-invasive monitor, recorded every 10 minutes from delivery until 2 hours postpartum.'}], 'secondaryOutcomes': [{'measure': 'Estimated blood loss (calculated)', 'timeFrame': '24 hours', 'description': 'Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 24 hours after the cesarean section.'}, {'measure': 'Estimated blood loss (weight)', 'timeFrame': '2 hours', 'description': 'Blood loss will be calculated by weighing the pads placed under the patient following delivery.'}, {'measure': 'Administration of uterotonic medication', 'timeFrame': '24 hours', 'description': 'Any oxytocin, ergonovine, carboprost, misoprostol administered following delivery'}, {'measure': 'Blood transfusion', 'timeFrame': '24 hours', 'description': 'The need for any transfusion of blood product following delivery.'}, {'measure': 'Surgical interventions', 'timeFrame': '24 hours', 'description': 'The need for manual placental removal, laceration/episiotomy repair, Bakri balloon, uterine artery ligation, hysterectomy, uterine artery/internal iliac artery embolization'}, {'measure': 'ICU admission', 'timeFrame': '24 hours', 'description': 'The need for admission to ICU following delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'postpartum hemorrhage', 'vaginal delivery', 'shock index', 'hemoglobin'], 'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': "Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity, and is most commonly caused by poor uterine tone after delivery of the baby and placenta. Currently, a lack of early identification of PPH also results in delayed treatment, with an increase in morbidity. The investigators propose that 2 non-invasive methods may provide monitoring for early and accurate detection of PPH. These methods include shock index (SI) and continuous hemoglobin (Hb) monitoring. SI is defined as heart rate divided by systolic blood pressure, and can be used as a marker to predict the severity of hypovolemic shock. Continuous Hb monitoring can now be done using a non-invasive probe that is placed on the patient's finger. It provides real-time Hb values, rather than having to draw blood and wait for a lab test.\n\nThe investigators hypothesize that SI will have a stronger association with postpartum blood loss than Hb variation.", 'detailedDescription': 'The investigators believe that trends in patient-specific SI combined with continuous SpHb monitoring, will be useful to identify PPH and the immediate need for pharmacotherapy, as well as the need for transfusion in obstetric patients undergoing vaginal deliveries. The investigators expect shock index to increase and SpHb levels to decrease with increasing blood loss after delivery. The compensatory hemodynamic response may start early, however, Hb variation may be delayed unless the patient is transfused with crystalloids. Also autotransfusion after delivery may influence these measures. It is unknown which one of the two indicators, SI or SpHb, has a stronger association with blood loss after vaginal delivery.\n\nIt is already established that both SI and SpHb are independent, clinically useful markers indicating significant blood loss in elective cesarean delivery and trauma. This study would assess their utility in the recognition and management of obstetric hemorrhage following normal vaginal delivery, where early recognition and resuscitation reduces the risk of progressing to hemorrhagic shock, disseminated intravascular coagulation and death.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women having an expected vaginal delivery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who give written consent to participate in this study\n* all term laboring patients including spontaneous and induced labor (gestational age \\>37 weeks) undergoing spontaneous vaginal delivery or instrumental delivery\n\nExclusion criteria\n\n* patients who refuse to give written informed consent\n* patients with cardiac rhythm abnormalities or cardiac diseases\n* patients undergoing elective/emergency CD\n* patients with jaundice\n* patients with abnormal Hb--\\>Such as Sickle cell disease and Thalassemia\n* patients with peripheral vascular disease\n* patients with hypertension and preeclampsia\n* patients on medications affecting blood pressure such as anti hypertensives (including Magnesium Sulphate), and those affecting HR (including beta blockers)'}, 'identificationModule': {'nctId': 'NCT03432767', 'briefTitle': 'Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '18-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women having a vaginal delivery', 'description': "A non-invasive hemoglobin monitor will be attached to the patient's finger and kept on for 2 hours after she delivers. Heart rate and blood pressure will be measured every 10 minutes.", 'interventionNames': ['Device: Non-invasive hemoglobin monitor']}], 'interventions': [{'name': 'Non-invasive hemoglobin monitor', 'type': 'DEVICE', 'armGroupLabels': ['Women having a vaginal delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Mrinalini Balki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}