NCT01980173: Bakri

Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care

Terminated NA Last updated 11 May 2018

What this trial tests

NA trial testing Routine care in Postpartum Hemorrhage in 26 participants. Terminated before completion.

Timeline

5 September 2014

Primary endpoint
26 September 2016

30 March 2017

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	26
Start date	5 September 2014
Primary completion	26 September 2016
Estimated completion	30 March 2017
Sites	7 locations across France

Drugs / interventions tested

• Routine care
• Bakri balloon

Conditions studied

• Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

18 and older, female only, with Postpartum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.