Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05191251
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3588}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity lab tests', 'timeFrame': '24 hours', 'description': 'Sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests will be calculated.\n\nFirstline hemostasis tests are aPTT, PT, INR, fibrinogen level and platelet count.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity hemorrhage', 'timeFrame': '24 hours', 'description': 'Sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage will be assessed.\n\nPostpartum hemorraghe is defined as blood loss greater then 500 mL for vaginal deliveries and greater than 1000 mL for cesarean sections.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripartum Period', 'Hemorrhage', 'HEMSTOP Questionnaire']}, 'referencesModule': {'references': [{'pmid': '27369959', 'type': 'BACKGROUND', 'citation': 'Bonhomme F, Boehlen F, Clergue F, de Moerloose P. Preoperative hemostatic assessment: a new and simple bleeding questionnaire. Can J Anaesth. 2016 Sep;63(9):1007-15. doi: 10.1007/s12630-016-0688-9. Epub 2016 Jul 1.'}, {'pmid': '23435255', 'type': 'BACKGROUND', 'citation': 'Bonhomme F, Ajzenberg N, Schved JF, Molliex S, Samama CM; French Anaesthetic and Intensive Care Committee on Evaluation of Routine Preoperative Testing; French Society of Anaesthesia and Intensive Care. Pre-interventional haemostatic assessment: Guidelines from the French Society of Anaesthesia and Intensive Care. Eur J Anaesthesiol. 2013 Apr;30(4):142-62. doi: 10.1097/EJA.0b013e32835f66cd.'}, {'pmid': '33127031', 'type': 'BACKGROUND', 'citation': 'Hawkins JL. Obstetric Hemorrhage. Anesthesiol Clin. 2020 Dec;38(4):839-858. doi: 10.1016/j.anclin.2020.08.010. Epub 2020 Oct 15.'}, {'pmid': '28937571', 'type': 'BACKGROUND', 'citation': 'Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.'}, {'pmid': '25103301', 'type': 'BACKGROUND', 'citation': 'Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.'}, {'pmid': '18715412', 'type': 'BACKGROUND', 'citation': 'Al-Zirqi I, Vangen S, Forsen L, Stray-Pedersen B. Prevalence and risk factors of severe obstetric haemorrhage. BJOG. 2008 Sep;115(10):1265-72. doi: 10.1111/j.1471-0528.2008.01859.x.'}, {'pmid': '32319687', 'type': 'BACKGROUND', 'citation': 'Butwick A, Lyell D, Goodnough L. How do I manage severe postpartum hemorrhage? Transfusion. 2020 May;60(5):897-907. doi: 10.1111/trf.15794. Epub 2020 Apr 22.'}, {'pmid': '32510319', 'type': 'BACKGROUND', 'citation': 'Hoyert DL, Minino AM. Maternal Mortality in the United States: Changes in Coding, Publication, and Data Release, 2018. Natl Vital Stat Rep. 2020 Jan;69(2):1-18.'}, {'pmid': '12558384', 'type': 'BACKGROUND', 'citation': 'Eckman MH, Erban JK, Singh SK, Kao GS. Screening for the risk for bleeding or thrombosis. Ann Intern Med. 2003 Feb 4;138(3):W15-24. doi: 10.7326/0003-4819-138-3-200302040-00011-w1.'}, {'pmid': '39917607', 'type': 'DERIVED', 'citation': 'Zec T, Schmartz D, Temmerman P, Fils JF, Ickx B, Bonhomme F, Van Der Linden P. Assessment of haemostasis in pregnant women: A retrospective evaluation of the diagnostic performance of the HEMSTOP standardised questionnaire. Eur J Anaesthesiol Intensive Care. 2024 Mar 15;3(2):e0050. doi: 10.1097/EA9.0000000000000050. eCollection 2024 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The diagnostic performance of the HEMSTOP (Hematoma, hEmorrhage, Menorrhagia, Surgery, Tooth extraction, Obstetrics, Parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be analyzed. The primary aim of the study is to assess the sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests. The second aim of the study is to assess the sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Full-term pregnant women', 'genderDescription': 'Fullterm pregnant women', 'eligibilityCriteria': 'Inclusion Criteria:\n\nFull-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.\n\nPatients who received follow-up during pregnancy as recommended. Age over 18\n\nExclusion Criteria:\n\nPatients age under the age of 18 Patients who did not have follow-up during pregnancy as recommended Patients taking long-term anticoagulants and/or antiaggregants Patients with a language barrier'}, 'identificationModule': {'nctId': 'NCT05191251', 'briefTitle': 'Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire', 'orgStudyIdInfo': {'id': 'CHUB-MAT-HEMSTOP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full-term pregnant women with HEMSTOP', 'description': 'Full-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.\n\nPatients who received follow-up during pregnancy as recommended. Age over 18', 'interventionNames': ['Diagnostic Test: HEMSTOP questionnaire']}], 'interventions': [{'name': 'HEMSTOP questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'A HEMSTOP questionnaire is obtained during the anesthesia consultation.', 'armGroupLabels': ['Full-term pregnant women with HEMSTOP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, department of Anesthesiology', 'investigatorFullName': 'Denis SCHMARTZ', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}