Thromboembolic DiseaseTHROM-PP2021NCT04883385
Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period
An observational study of Thromboembolic Disease, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thromboembolic Disease
- What is being tested?
- medical data collection
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2021to 9 Jul 2022
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: All patients who had given birth at Centre Hospitalier Sud Francilien
Who may be able to join
- >18 ages
- Who had given birth at Centre Hospitalier Sud Francilien
- Hospitalized during the puerperium at Centre Hospitalier Sud Francilien
- Being informed of the clinical trial and had offered any opposition for data collection
Who cannot join
- Curative treatment of thrombosis by Low molecular-weight or unfractioned heparin during pregnancy or post-partum period
- Curative anticoagulant therapy for any cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence Between Thromboprophylaxis Prescriptions and Guidelines During the Post-partum Period After the Institution of a Local Protocol
The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines.
Read the detailed description
Venous thromboembolism (VTE) became the 4th cause of maternal mortality and the 2nd direct cause of maternal mortality in France.
The re are only few randomized studies on the thromboprophylaxis during the post-partum period. This expose some discrepancy between French guidelines, French Society of Anesthesia \& Intensive Care Medecine (SFAR) and National College of French Gynecologists and Obstetricians (CNGOF ).
The duration and adequate dose of low molecular heparin prescriptions are unclear.
The level of adequacy of thromboprophylaxis prescriptions at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.
Since this assessment, institutional protocol synthesizing thromboprophylaxis guidelines during the post-partum was exposed and validated among medical staff (both anaesthesiologists ang obstetricians).
- Conditions
- Thromboembolic Disease
- Being tested
- medical data collection
- Keywords
- Thromboembolic disease, Thromboprophylaxis, Post-partum period, Pregnancy, low molecular heparin
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical data collectionOther
collection of medical data from patients' medical records
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period
Measured: at one year
Secondary outcomes (3)
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.
Measured: at one year
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section
Measured: at one year
causes of non-compliant prescriptions with the institutional protocol.
Identify the causes of non-compliant prescriptions with the institutional protocol.
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start8 Oct 2021
- Primary completion9 Jul 2022
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa BROCAS, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883385
- Sponsor's protocol ID
- 2021/0016
- Acronym
- THROM-PP2021
- Status last verified
- Sep 2022
- First submitted
- 5 May 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Between Thromboprophylaxis Prescriptions and Guidelines During the Post-partum Period After the Institution of a Local Protocol
- ClinicalTrials.gov ID
- NCT04883385
- Acronym / sponsor ID
- THROM-PP2021 / 2021/0016
- Conditions
- Thromboembolic Disease
- Keywords
- Thromboembolic disease, Thromboprophylaxis, Post-partum period, Pregnancy, low molecular heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 12 May 2021 (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.
The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines.
Detailed description
Venous thromboembolism (VTE) became the 4th cause of maternal mortality and the 2nd direct cause of maternal mortality in France.
The re are only few randomized studies on the thromboprophylaxis during the post-partum period. This expose some discrepancy between French guidelines, French Society of Anesthesia \& Intensive Care Medecine (SFAR) and National College of French Gynecologists and Obstetricians (CNGOF ).
The duration and adequate dose of low molecular heparin prescriptions are unclear.
The level of adequacy of thromboprophylaxis prescriptions at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.
Since this assessment, institutional protocol synthesizing thromboprophylaxis guidelines during the post-partum was exposed and validated among medical staff (both anaesthesiologists ang obstetricians).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All patients who had given birth at Centre Hospitalier Sud Francilien
Key inclusion criteria (4 listed)
- >18 ages
- Who had given birth at Centre Hospitalier Sud Francilien
- Hospitalized during the puerperium at Centre Hospitalier Sud Francilien
- Being informed of the clinical trial and had offered any opposition for data collection
Key exclusion criteria (2 listed)
- Curative treatment of thrombosis by Low molecular-weight or unfractioned heparin during pregnancy or post-partum period
- Curative anticoagulant therapy for any cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical data collectioncollection of medical data from patients' medical records | Other | – |
Primary outcome
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period
Time frame: at one year
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period
3 secondary outcomes
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.
Time frame: at one year
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section
Time frame: at one year
causes of non-compliant prescriptions with the institutional protocol.
Time frame: at one year
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 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Elsa BROCAS, MD principal investigator
Centre Hospitalier Sud Francilien
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 Thromboembolic Disease, run by Centre Hospitalier Sud Francilien 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 4 inclusion and 2 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 15 Sep 2022. 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?
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period (time frame: at one year). 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 15 Sep 2022.