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NCT06164236 Clinical Trial

Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

— NALAPOST  

Official title:
Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06164236
Other study ID # 8013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 19, 2020
Est. completion date December 31, 2023

Study information
Verified date December 2022
Source University Hospital, Strasbourg, France
Contact Sandrine VOILLEQUIN, Midwife
Phone 33 3 69 55 34 92
Email sandrine.voillequin@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Major subject (=18 years old) - Subject having given birth at HUS or CHU Poissy Saint-Germain-en Laye between 01/01/2019 and 31/12/2019 - 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 Exclusion Criteria: - Subject having expressed opposition to participating in the study - Subject under guardianship or guardianship - Subject under safeguard of justice

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France École de sages-femmes de Strasbourg Strasbourg Starsbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify a potential predictors of failure of second-line drug treatment in the case of severe postpartum hemorrhage 1 year
See also
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Completed NCT02805426 - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage Phase 4
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