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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Postpartum Hemorrhage

Treatments: Device: Bakri balloon; Procedure: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT01980173

LOCAL/2012/VL-04

2013-A00914-41 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient, her person-of-trust, must have given his/her consent and signed the consent form / inclusion decision made by the investigator when a person-of-trust is absent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is able to fluently read and speak French
• Blood loss > 500ml and sulprostone treatment is insufficient at 20 minutes
• Duration of pregnancy > 32 weeks of amenorrhea
• Uterine atony

Exclusion criteria

• The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient cannot read French
• The patient was transferred to another center not among the centers participating in this study
• The patient has a contraindication for a treatment used in this study (Sulprostone), or an incompatible treatment combination
• The patient has a contraindication for third level techniques
• The patient has at least one of the following conditions: chorioamnionitis, cervical cancer, uterine rupture, anatomical abnormality preventing the introduction of the device, purulent infection of the vagina, cervix or uterus.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

With Bakri balloon

Experimental group

Description:

Patients randomized to this arm will be treated using the Bakri balloon. Intervention: Bakri balloon

Treatment:

Device: Bakri balloon

Without Bakri balloon

Active Comparator group

Description:

Patients randomized to this arm will receive routine care not including the Bakri Balloon. Intervention: Routine Care

Treatment:

Procedure: Routine care