Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage (NALAPOST)

December 23, 2024 updated by: University Hospital, Strasbourg, France

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Starsbourg
      • Strasbourg, Starsbourg, France, 67091
        • École de sages-femmes de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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 31/12/2020
  • 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

Exclusion Criteria:

  • Subject having expressed opposition to participating in the study
  • Subject under guardianship or guardianship
  • Subject under safeguard of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

April 19, 2024

Study Completion (Actual)

April 19, 2024

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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