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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06970860
Acronym
DIDAPPH
Enrollment
150
Registered
2025-05-14
Start date
2025-11-15
Completion date
2029-09-15
Last updated
2025-10-02

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

Conditions

Severe Postpartum Hemorrhage

Keywords

Postpartum hemorrhage, bleeding disorders

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Rate of biological test results suggestive of a bleeding disorder, correlated with the clinical bleeding phenotype, within the cohortFrom inclusion to three month

Secondary

MeasureTime frame
Number of hereditary types of bleeding disorders diagnosed within the cohort based on the biological test resultsFrom inclusion to three month
Number of acquired types of bleeding disorders within the cohort based on the biological test resultsFrom inclusion to three month
Plasma levels of blood biomarkers associated with severe postpartum hemorrhage (PPH), as identified in another genetic study, among patients from the DIDAPPH cohort based on the biological test resultsInclusion
Frequency of genetic polymorphisms associated with severe postpartum hemorrhage identified in another genetic study among patients from the DIDAPPH cohort based on the biological test resultsInclusion

Countries

France

Contacts

Primary ContactClaire DE MOREUIL
claire.demoreuil@chu-brest.fr+330298145303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026