Clinical trial NCT06970860: Detection of Bleeding Disorders Diagnosed After Vaginal Delivery Complicated by Severe Postpartum Hemorrhage
Official title: Detection of Bleeding Disorders Diagnosed After Vaginal Delivery Complicated by Severe Postpartum Hemorrhage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
bleeding disorders
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The women included in the study will be adult women who experienced severe postpartum hemorrhage, defined as blood loss ≥1000 mL after a vaginal delivery. These women will be identified by the teams from the maternity units in Finistère.

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.

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.

Primary outcomes:
measure: Rate of biological test results suggestive of a bleeding disorder, correlated with the clinical bleeding phenotype, within the cohort
timeFrame: From inclusion to three month
Secondary outcomes:
measure: Number of hereditary types of bleeding disorders diagnosed within the cohort based on the biological test results
timeFrame: From inclusion to three month
measure: Number of acquired types of bleeding disorders within the cohort based on the biological test results
timeFrame: From inclusion to three month
measure: 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 results
timeFrame: Inclusion
measure: 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 results
timeFrame: Inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: