An observational study in Severe Postpartum Hemorrhage, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by University Hospital, Brest · Observational
A cohort study designed to detect bleeding disorders diagnosed in women who experienced severe postpartum hemorrhage after vaginal delivery
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.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 150 is below the median of 169 across 96 observational studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Rate of biological test results suggestive of a bleeding disorder, correlated with the clinical bleeding phenotype, within the cohort
Time frame: From inclusion to three month
Number of hereditary types of bleeding disorders diagnosed within the cohort based on the biological test results
Time frame: From inclusion to three month
Number of acquired types of bleeding disorders within the cohort based on the biological test results
Time frame: From 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 results
Time frame: Inclusion
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
Time frame: Inclusion
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
No publications or documents are linked to this record.
Start is estimated for Nov 2025; primary completion for Sep 2029, 46 months later.
Of 38 non-industry observational studies under Postpartum Hemorrhage, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 46 months is above that.
Counting every sponsor, half of 42 studies reached it within 21 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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