NCT06164236

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

November 2, 2020

Last Update Submit

December 23, 2024

Conditions

Keywords

Postpartum haemorrhageMaternal morbidityOxytocinSulprostoneUterine HemorrhageObstetric Labor Complications

Outcome Measures

Primary Outcomes (1)

  • This a rétrospective study trayning to identify a potential predictors of failure of second-line drug treatment in the case of severe postpartum hemorrhage

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

École de sages-femmes de Strasbourg

Strasbourg, Starsbourg, 67091, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postpartum HemorrhageUterine HemorrhageObstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

December 11, 2023

Study Start

October 19, 2020

Primary Completion

April 19, 2024

Study Completion

April 19, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations