Detection of Bleeding Disorders Diagnosed After Vaginal Delivery Complicated by Severe Postpartum Hemorrhage

NCT ID: NCT06970860

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2029-09-15

Brief Summary

A cohort study designed to detect bleeding disorders diagnosed in women who experienced severe postpartum hemorrhage after vaginal delivery

Detailed Description

Severe postpartum hemorrhage (PPH), defined as blood loss ≥ 1000 mL within 24 hours after delivery, is a common complication of childbirth (2% of deliveries in France and Europe). It is associated with significant maternal morbidity and mortality. Moreover, the incidence of PPH has been increasing in high-resource countries since the 1990s, making it a major public health issue.

Research conducted by our group on the Finistère cohort of pregnant women, highlighted that a first-degree family history of PPH is a risk factor for severe PPH after vaginal delivery, with an Odds Ratio of 2.37 (95% CI 1.56-3.60). These findings suggest a familial predisposition to PPH.

Furthermore, von Willebrand disease is the most common hereditary bleeding disorder worldwide, with an estimated prevalence between 0.6% and 1.3%. The most common form, type 1 von Willebrand disease, is inherited in an autosomal dominant manner.

There is limited data in the literature regarding the prevalence of bleeding disorders diagnosed following PPH in the general population. However, PPH is a frequent complication of childbirth in women with von Willebrand disease, with the prevalence of primary severe PPH being 2 to 4 times higher compared to the general population.

The research hypothesis of the DIDAPPH study is that severe PPH could be a presenting feature of previously undiagnosed von Willebrand disease.

If constitutional bleeding disorders were frequently diagnosed after severe PPH, then their systematic screening could be a public health priority for women of childbearing age and might enable more effective prevention of hemorrhagic complications during delivery, through prophylactic drug treatments, in subsequent pregnancies. Additionally, diagnosing von Willebrand disease in these women would have the added benefit of better preventing hemorrhagic complications after invasive procedures outside of pregnancy, particularly surgical ones, throughout their lifetime.

Conditions

Severe Postpartum Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort of women who experienced severe postpartum hemorrhage following a vaginal delivery.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Women ≥ 18 years old
• Who experienced severe postpartum hemorrhage, defined as blood loss ≥ 1000 mL, following a vaginal delivery in the previous 12 months, in a maternity unit in Finistère

Exclusion Criteria

• Women who are pregnant at the time of inclusion
• Women with a known hereditary bleeding disorder (Willebrand's disease, hemophilia carrier, etc.) or acute or chronic Immune thrombocytopenia (ITP) prior to delivery.
• Women with a known other bleeding pathology prior to delivery
• Women taking a treatment that interferes with hemostasis, such as aspirin, anticoagulants or non-steroidal anti-inflammatory drugs (biological sampling may be postponed until after the interfering treatment has stopped, in the case of occasional use of the latter).
• Women on long-term anticoagulant or antiaggregant therapy
• Women under legal protection,
• Women not affiliated to the French social security system.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Brest

Brest, , France

Countries

France

Central Contacts

Claire DE MOREUIL

Role: CONTACT

claire.demoreuil@chu-brest.fr

+330298145303

Facility Contacts

Brigitte PAN-PETESCH

Role: primary

brigitte.pan-petesch@chu-brest.fr

+330298223989

Other Identifiers

29BRC24.0169

Identifier Type: -

Identifier Source: org_study_id