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

Completed

• Conditions: Peripartum Period; HEMSTOP Questionnaire; Hemorrhage
• Interventions: Diagnostic Test: HEMSTOP questionnaire

• Registration Number: NCT05191251
• Lead Sponsor: Brugmann University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study Start: 2022-01-13
• Study First Posted: 2022-01-13
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3588

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full-term pregnant women with HEMSTOP	HEMSTOP questionnaire	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium