Postpartum HemorrhageHEMOTHEPPNCT02443610
Haemorrhages and Thromboembolic Venous Disease of the Postpartum
An observational study of Postpartum Hemorrhage and Venous Thromboembolism, run by University Hospital, Brest at 6 sites in France.
Trial summary
The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France) Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Venous Thromboembolism
- How many people
- 20,241 participants
- Where
- 6 sitesFrance
- Study dates
- 6 Jan 2015to 27 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women admitted for delivery in a maternity Finistère
Who may be able to join
- Any woman giving birth and supported in one of Gynaecology Obstetrics services of a maternity Finistere.
- Women ≥ 16 at the time of the collection of non-opposition.
- For minor patients: understanding the patient and at least one parent.
- All births ≥ 15 weeks gestation.
Who cannot join
- Home Birth
- Expressed opposition to participation in this study.
- Childbirth under X.
- Parent (s) uninformed of the pregnancy of their child.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHRU de Brest - Service de Gynécologie-obstétrique
Brest, 29609
Clinique Keraudren
Brest
CH de Carhaix
Carhaix-Plouguer, Finistère, 29270
CH de Landerneau
Landerneau
CH de Morlaix
Morlaix
CH Quimper
Quimper
About this study
Official title: Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques
The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)
Read the detailed description
This is an analytical observational prospective multicenter cohort study , conducted on all the maternity hospitals in Finistère (Bretagne - France), with a biological collection.
This protocol allows to study all women at risk of PPH (Postpartum Hemorrhage) and postpartum venous thromboembolic disease, including maternity level 1-3 without case selection. The prospective nature of the study should provide a more detailed analysis of exposures in this particular population of women (risk factors related to the field, childbirth, the postpartum events ...).
The events of interest were PPH and venous thromboembolic disease.
- Conditions
- Postpartum Hemorrhage, Venous Thromboembolism
- Keywords
- Postpartum Hemorrhage, Venous Thromboembolism, Pregnancy
- Medical subject headings
- Postpartum Hemorrhage, Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Hemorrhage
Volume of blood loss up to 48 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician
Measured: 2 days
Symptomatic thromboembolic events
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start6 Jan 2015
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 20,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PAN PETESCH Brigitte, Principal investigator, Unité d'Hémostase , Centre Régional de traitement de l'hémophilie et des maladies hémorragiques, CHRU de Brest (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443610
- Sponsor's protocol ID
- HEMOTHEPP ( RB 13.175)
- Acronym
- HEMOTHEPP
- Status last verified
- May 2023
- First submitted
- 5 May 2015
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Anouilh F, de Moreuil C, Tremouilhac C, Jacquot M, Salnelle G, Bellec V, Touffet N, Cornec C, Muller M, Dupre PF, Bellot C, Morcel K, Joliff DL, Drugmanne G, Gelebart E, Lucier S, Nowak E, Bihan L, Couturaud F, Tromeur C, Moigne EL, Pan-Petesch B. Family history of postpartum hemorrhage is a risk factor for postpartum hemorrhage after vaginal delivery: results from the French prospective multicenter Haemorrhages and Thromboembolic Venous Disease of the Postpartum cohort study. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101062. doi: 10.1016/j.ajogmf.2023.101062. Epub 2023 Jun 19.
PubMed 37343695
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques
- ClinicalTrials.gov ID
- NCT02443610
- Acronym / sponsor ID
- HEMOTHEPP / HEMOTHEPP ( RB 13.175)
- Conditions
- Postpartum Hemorrhage, Venous Thromboembolism
- Keywords
- Postpartum Hemorrhage, Venous Thromboembolism, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,241 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)
Detailed description
This is an analytical observational prospective multicenter cohort study , conducted on all the maternity hospitals in Finistère (Bretagne - France), with a biological collection.
This protocol allows to study all women at risk of PPH (Postpartum Hemorrhage) and postpartum venous thromboembolic disease, including maternity level 1-3 without case selection. The prospective nature of the study should provide a more detailed analysis of exposures in this particular population of women (risk factors related to the field, childbirth, the postpartum events ...).
The events of interest were PPH and venous thromboembolic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women admitted for delivery in a maternity Finistère
Key inclusion criteria (4 listed)
- Any woman giving birth and supported in one of Gynaecology Obstetrics services of a maternity Finistere.
- Women ≥ 16 at the time of the collection of non-opposition.
- For minor patients: understanding the patient and at least one parent.
- All births ≥ 15 weeks gestation.
Key exclusion criteria (4 listed)
- Home Birth
- Expressed opposition to participation in this study.
- Childbirth under X.
- Parent (s) uninformed of the pregnancy of their child.
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
Postpartum Hemorrhage
Time frame: 2 days
Volume of blood loss up to 48 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician
Symptomatic thromboembolic events
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 37343695Anouilh F, de Moreuil C, Tremouilhac C, Jacquot M, Salnelle G, Bellec V, Touffet N, Cornec C, Muller M, Dupre PF, Bellot C, Morcel K, Joliff DL, Drugmanne G, Gelebart E, Lucier S, Nowak E, Bihan L, Couturaud F, Tromeur C, Moigne EL, Pan-Petesch B. Family history of postpartum hemorrhage is a risk factor for postpartum hemorrhage after vaginal delivery: results from the French prospective multicenter Haemorrhages and Thromboembolic Venous Disease of the Postpartum cohort study. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101062. doi: 10.1016/j.ajogmf.2023.101062. Epub 2023 Jun 19.
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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. This study is not recruiting at the moment.
PAN PETESCH Brigitte principal investigator
Unité d'Hémostase , Centre Régional de traitement de l'hémophilie et des maladies hémorragiques, CHRU de Brest (France)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage and Venous Thromboembolism, run by University Hospital, Brest at 6 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Hemorrhage (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443610, which also lists 1 linked publication.
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 1 Jun 2023.