Clinical trial NCT05191251: Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire
Official title: Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripartum Period
Hemorrhage
HEMSTOP Questionnaire
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 3588
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term pregnant women

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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.

Patients who received follow-up during pregnancy as recommended. Age over 18

Exclusion Criteria:

Patients 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

Primary outcomes:
measure: Sensitivity and specificity lab tests
timeFrame: 24 hours
Secondary outcomes:
measure: Sensitivity and specificity hemorrhage
timeFrame: 24 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.