Severe Postpartum HemorrhageDIDAPPHNCT06970860
Detection of Bleeding Disorders Diagnosed After Vaginal Delivery Complicated by Severe Postpartum Hemorrhage
An observational study of Severe Postpartum Hemorrhage, run by University Hospital, Brest at 1 site in France.
Trial summary
A cohort study designed to detect bleeding disorders diagnosed in women who experienced severe postpartum hemorrhage after vaginal delivery Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Postpartum Hemorrhage
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2025to 15 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Brest
Brest, 29200
Brigitte PAN-PETESCH, +330298223989, brigitte.pan-petesch@chu-brest.fr
About this study
A cohort study designed to detect bleeding disorders diagnosed in women who experienced severe postpartum hemorrhage after vaginal delivery
Read the 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
- Keywords
- Postpartum hemorrhage, bleeding disorders
- Medical subject headings
- Postpartum Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of women who experienced severe postpartum hemorrhage following a vaginal delivery. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of biological test results suggestive of a bleeding disorder, correlated with the clinical bleeding phenotype, within the cohort
Measured: From inclusion to three month
Secondary outcomes (4)
Number of hereditary types of bleeding disorders diagnosed within the cohort based on the biological test results
Measured: From inclusion to three month
Number of acquired types of bleeding disorders within the cohort based on the biological test results
Measured: 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
Measured: 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
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Sep 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970860
- Sponsor's protocol ID
- 29BRC24.0169
- Acronym
- DIDAPPH
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bleeding Disorders Diagnosed After Vaginal Delivery Complicated by Severe Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT06970860
- Acronym / sponsor ID
- DIDAPPH / 29BRC24.0169
- Conditions
- Severe Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, bleeding disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Sep 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of women who experienced severe postpartum hemorrhage following a vaginal delivery. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Postpartum Hemorrhage, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire DE MOREUIL (+330298145303, claire.demoreuil@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.