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

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

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.

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.