Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-07 @ 9:01 AM
Study NCT ID:
NCT06431204
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2024-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstetric Comorbidity Index in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 583}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prediction of severe maternal morbidity using obstetric comorbidity index', 'timeFrame': 'in 72 hours after cesarean delivery', 'description': 'The prediction of severe maternal morbidity using obstetric comorbidity index presented in C-statistic (AUC of ROC)'}], 'secondaryOutcomes': [{'measure': 'Rate of blood transfusion', 'timeFrame': 'in 72 hours after cesarean delivery', 'description': 'Perioperative red blood cells transfusion in units'}, {'measure': 'Quantity of postpartum hemorrhage', 'timeFrame': 'in 24 hours after cesarean delivery', 'description': 'Quantity of postpartum hemorrhage in ml.'}, {'measure': 'Cause of postpartum hemorrhage', 'timeFrame': 'in 24 hours after cesarean delivery', 'description': 'Main cause of postpartum hemorrhage'}, {'measure': 'Rate of ICU admission', 'timeFrame': 'in 24 hours after cesarean delivery', 'description': 'Rate of intensive care unit admission'}, {'measure': 'Rate of Postoperative complications', 'timeFrame': 'in 72 hours after cesarean delivery', 'description': 'Post operative complications eg. congestive heart failure, TRALI, acute kidney injury'}, {'measure': 'Neonatal Apgar score', 'timeFrame': 'at 1-minute and 5-minute after delivery', 'description': 'Neonatal Apgar score from 0 - 10'}, {'measure': 'Rate of maternal mortality', 'timeFrame': 'in 72 hours after cesarean delivery', 'description': 'Maternal death rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'postpartum hemorrhage', 'maternal morbidity', 'obstetrics comorbidity index'], 'conditions': ['Cesarean Section Complications', 'Postpartum Hemorrhage', 'Morbidity;Perinatal']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine the predictive capability of the Obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery.', 'detailedDescription': "The prospectively predictive maternal morbidity is imperative to enhance maternal outcomes. There has been development of the obstetric comorbidity index (OBCMI) by Bateman et al. in 2013 and performed with superior performance characteristics relative to general comorbidity measures in an obstetric population. The score has been a growing recognition of the necessity for specialized risk assessment tools tailored specifically to obstetric populations that differ from other populations. For instance, both the Charlson/Romano comorbidity index or the Elixhauser comorbidity score and their adaptations are deficient in accounting for obstetric conditions, thereby limiting their ability to predict obstetric morbidity or mortality.\n\nThe Obstetric Comorbidity Index has undergone thorough examination and validation across multiple nations. These findings collectively demonstrate the index's capacity for moderate to high predictive accuracy in anticipating maternal morbidities, accompanied by a commendable discriminative performance.\n\nHowever, within the context of Thailand, investigations concerning the Obstetric Comorbidity Index and its association with perioperative complications or morbidities in postpartum hemorrhage patients undergoing cesarean delivery remain unexplored. Therefore, this study aims to elucidate the correlation between the Obstetric Comorbidity Index and severe maternal morbidity, while also scrutinizing the prevalence of comorbidities during the perioperative period among patients undergoing cesarean delivery at the largest University hospital, in THAILAND. Predicting the rate of maternal morbidity would be advantageous for facilitating preparation and augmenting awareness of complications during the perioperative period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The chart of patients who underwent cesarean delivery with the diagnosis of postpartum hemorrhage (bleeding \\>, = 1,000 ml) and gestational age of more than 24 weeks.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1)\n\nExclusion Criteria:\n\n* Cesarean delivery at less than 24 weeks of gestation\n* A patient chart that does not contain primary outcome data eg. absence of anesthetic record\n* Blood loss less than 1,000 ml in the first 24 hours postpartum'}, 'identificationModule': {'nctId': 'NCT06431204', 'briefTitle': 'Obstetric Comorbidity Index in Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Obstetric Comorbidity Index for Prediction of Perioperative Severe Maternal Morbidity in Patients Undergoing Cesarean Delivery With Postpartum Hemorrhage', 'orgStudyIdInfo': {'id': '351/2567(IRB2)'}, 'secondaryIdInfos': [{'id': 'Si 359/2024', 'type': 'OTHER', 'domain': 'Siriraj Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with postpartum hemorrhage with severe maternal morbidity', 'description': 'Patients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications)', 'interventionNames': ['Other: Obstetric comorbidity index']}, {'label': 'Patients with postpartum hemorrhage without severe maternal morbidity', 'description': 'Patients without the severe maternal morbidity conditions', 'interventionNames': ['Other: Obstetric comorbidity index']}], 'interventions': [{'name': 'Obstetric comorbidity index', 'type': 'OTHER', 'description': 'Obstetric comorbidity index score', 'armGroupLabels': ['Patients with postpartum hemorrhage with severe maternal morbidity', 'Patients with postpartum hemorrhage without severe maternal morbidity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators may balance the potential benefits and risks for each request and then provide the data that could be shared, together with the permission from the hospital director.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}