Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire

NCT05191251 | Completed

• 1 other identifier: CHUB-MAT-HEMSTOP
• Study Type: observational
• Target: 3,588
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripartum Period; Hemorrhage; HEMSTOP Questionnaire

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity lab tests

  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. Firstline hemostasis tests are aPTT, PT, INR, fibrinogen level and platelet count.

  24 hours

Secondary Outcomes (1)

• Sensitivity and specificity hemorrhage

  24 hours

Study Arms (1)

Full-term pregnant women with HEMSTOP

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

Diagnostic Test: HEMSTOP questionnaire

Interventions

HEMSTOP questionnaire DIAGNOSTIC_TEST

A HEMSTOP questionnaire is obtained during the anesthesia consultation.

Full-term pregnant women with HEMSTOP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Fullterm pregnant women
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Full-term pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (10)

• 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: 27369959 BACKGROUND

• 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: 23435255 BACKGROUND

• 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: 33127031 BACKGROUND

• 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: 28937571 BACKGROUND

• 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: 25103301 BACKGROUND

• 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: 18715412 BACKGROUND

• 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: 32319687 BACKGROUND

• 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: 32510319 BACKGROUND

• 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: 12558384 BACKGROUND

• 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.

  PMID: 39917607 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, department of Anesthesiology

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: January 13, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)