Postpartum HemorrhageNALAPOSTNCT06164236
Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The investigators wish to identify potential factors predicting failure of second-line drug treatment (sulproston (Nalador®)): risk factors and factors linked to a failure to take initial care for PPH. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2020to 19 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult person (≥18 years old) who gave birth at HUS or at Poissy Saint-Germain-en Laye university hospital between 01/01/2019 and 12/31/2020 and having presented a postpartum hemorrhage treated with Sulprostone
Who may be able to join
- Major subject (≥18 years old)
- Subject having given birth at HUS or CHU Poissy Saint-Germain-en Laye between 01/01/2019 and 31/12/2020
- Subject having presented a postpartum haemorrhage treated with Sulprostone
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
The investigators wish to identify potential factors predicting failure of second-line drug treatment (sulproston (Nalador®)): risk factors and factors linked to a failure to take initial care for PPH.
A better understanding of the aggravating factors of HPP and more particularly the factors inherent to the initial care would make it possible to think of ways to improve practices.
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum haemorrhage, Maternal morbidity, Oxytocin, Sulprostone, Uterine Hemorrhage, Obstetric Labor Complications
- Medical subject headings
- Postpartum Hemorrhage, Uterine Hemorrhage, Obstetric Labor Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
This a rétrospective study trayning to identify a potential predictors of failure of second-line drug treatment in the case of severe postpartum hemorrhage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start19 Oct 2020
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
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, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164236
- Sponsor's protocol ID
- 8013
- Acronym
- NALAPOST
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2020
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voillequin S, Meyer MN, Faraci F, Rozenberg MP, Rousseau A. Maternal and clinical characteristics associated with sulprostone failure in postpartum haemorrhage after vaginal delivery: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2026 Feb;317:114862. doi: 10.1016/j.ejogrb.2025.114862. Epub 2025 Nov 28.
PubMed 41319511
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT06164236
- Acronym / sponsor ID
- NALAPOST / 8013
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum haemorrhage, Maternal morbidity, Oxytocin, Sulprostone, Uterine Hemorrhage, Obstetric Labor Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 11 Dec 2023 (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 investigators wish to identify potential factors predicting failure of second-line drug treatment (sulproston (Nalador®)): risk factors and factors linked to a failure to take initial care for PPH.
A better understanding of the aggravating factors of HPP and more particularly the factors inherent to the initial care would make it possible to think of ways to improve practices.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult person (≥18 years old) who gave birth at HUS or at Poissy Saint-Germain-en Laye university hospital between 01/01/2019 and 12/31/2020 and having presented a postpartum hemorrhage treated with Sulprostone
Key inclusion criteria (4 listed)
- Major subject (≥18 years old)
- Subject having given birth at HUS or CHU Poissy Saint-Germain-en Laye between 01/01/2019 and 31/12/2020
- Subject having presented a postpartum haemorrhage treated with Sulprostone
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
This a rétrospective study trayning to identify a potential predictors of failure of second-line drug treatment in the case of severe postpartum hemorrhage
Time frame: 1 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 27 Dec 2024.
- Derived from this study: PubMed 41319511Voillequin S, Meyer MN, Faraci F, Rozenberg MP, Rousseau A. Maternal and clinical characteristics associated with sulprostone failure in postpartum haemorrhage after vaginal delivery: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2026 Feb;317:114862. doi: 10.1016/j.ejogrb.2025.114862. Epub 2025 Nov 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Strasbourg, France 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 3 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 27 Dec 2024. 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?
This a rétrospective study trayning to identify a potential predictors of failure of second-line drug treatment in the case of severe postpartum hemorrhage (time frame: 1 year). 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 NCT06164236, 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 27 Dec 2024.