Postpartum HemorrhageHPP-IPFNCT02884804
Study of Biological Determinants of Bleeding Postpartum
An observational study of Postpartum Hemorrhage, run by University Hospital, Brest at 1 site in France.
Trial summary
At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices. The percentage of the immature platelets is a an additional parameter on the hemogram. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- How many people
- 3,599 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to May 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Woman giving birth in a maternity of Finistère (France)
Who may be able to join
- Woman giving birth in a maternity of Finistère
Who cannot join
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Biological Determinants of Bleeding Postpartum : Predictive Role in the Number of Immature Platelets
At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices.
The percentage of the immature platelets is a an additional parameter on the hemogram.
The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum Hemorrhage, Immature platelet
- Medical subject headings
- Postpartum Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Hemorrhage
Measured: Volume of blood loss up to 24 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician
Percentage of immature platelets
Measured: Percentage of immature platelets just before the entry in the birth room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startNov 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3,599 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PAN-PETESCH Brigitte, Dr., Principal investigator, CHRU de BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884804
- Sponsor's protocol ID
- HPP-IPF (RB 11.080)
- Acronym
- HPP-IPF
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biological Determinants of Bleeding Postpartum : Predictive Role in the Number of Immature Platelets
- ClinicalTrials.gov ID
- NCT02884804
- Acronym / sponsor ID
- HPP-IPF / HPP-IPF (RB 11.080)
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum Hemorrhage, Immature platelet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,599 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Aug 2016 (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.
At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices.
The percentage of the immature platelets is a an additional parameter on the hemogram.
The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Woman giving birth in a maternity of Finistère (France)
Key inclusion criteria (1 listed)
- Woman giving birth in a maternity of Finistère
Key exclusion criteria (1 listed)
- Refuse to participate in the study
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: Volume of blood loss up to 24 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician
Percentage of immature platelets
Time frame: Percentage of immature platelets just before the entry in the birth room
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 31 Aug 2016.
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
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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, Dr. principal investigator
CHRU de BREST
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 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 1 inclusion and 1 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 31 Aug 2016. 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?
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: Volume of blood loss up to 24 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician). 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?
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 31 Aug 2016.