NCT06970860

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-11-15
• Primary completion: 2029-09-15
• Completion: 2029-09-15
• First posted: 2025-05-14
• Last updated: 2025-10-02

Locations

1 site across 1 country: France