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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05191251
Enrollment
3588
Registered
2022-01-13
Start date
2022-01-13
Completion date
2022-06-30
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage, HEMSTOP Questionnaire, Peripartum Period

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.

Interventions

DIAGNOSTIC_TESTHEMSTOP questionnaire

A HEMSTOP questionnaire is obtained during the anesthesia consultation.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity lab tests24 hoursSensitivity 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

MeasureTime frameDescription
Sensitivity and specificity hemorrhage24 hoursSensitivity 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026