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

Sponsor
Brugmann University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05191251
Collaborator
(none)
6,000
1
3.5
1706.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HEMSTOP questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
6000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire
Actual Study Start Date :
Jan 13, 2022
Anticipated Primary Completion Date :
Apr 10, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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
A HEMSTOP questionnaire is obtained during the anesthesia consultation.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and specificity lab tests [24 hours]

    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.

Secondary Outcome Measures

  1. Sensitivity and specificity hemorrhage [24 hours]

    Sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage will be assessed. Postpartum hemorraghe is defined as blood loss greater then 500 mL for vaginal deliveries and greater than 1000 mL for cesarean sections.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Brugmann Brussels Belgium 1020

Sponsors and Collaborators

  • Brugmann University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Denis SCHMARTZ, Head, department of Anesthesiology, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT05191251
Other Study ID Numbers:
  • CHUB-MAT-HEMSTOP
First Posted:
Jan 13, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022