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

NCT ID: NCT05191251

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3588 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-13

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripartum Period Hemorrhage HEMSTOP Questionnaire

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

HEMSTOP questionnaire

Intervention Type DIAGNOSTIC_TEST

A HEMSTOP questionnaire is obtained during the anesthesia consultation.

Interventions

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HEMSTOP questionnaire

A HEMSTOP questionnaire is obtained during the anesthesia consultation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denis SCHMARTZ

Head, department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 27369959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23435255 (View on PubMed)

Hawkins JL. Obstetric Hemorrhage. Anesthesiol Clin. 2020 Dec;38(4):839-858. doi: 10.1016/j.anclin.2020.08.010. Epub 2020 Oct 15.

Reference Type BACKGROUND
PMID: 33127031 (View on PubMed)

Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

Reference Type BACKGROUND
PMID: 28937571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25103301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18715412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32319687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32510319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12558384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39917607 (View on PubMed)

Other Identifiers

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CHUB-MAT-HEMSTOP

Identifier Type: -

Identifier Source: org_study_id

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