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Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage

NCT02226731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2025-09-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory to first-line uterotonic treatment, ie performed at the same time as second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case of failure of second line uterotonic treatment, on the final severity of PPH. ).

Conditions

  • Immediate Postpartum Hemorrhage

Interventions

DEVICE

Early Belfort-Dildy Balloon

Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.

DEVICE

Late Belfort-Dildy balloon

Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Patrick ROZENBERG, MD · Department of Obstetrics, Poissy-Saint Germain Hospital Center

  • Catherine DENEUX - THARAUX, MD, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2020-06-30
Completion
2020-08-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02226731 on ClinicalTrials.gov