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

NCT ID: NCT01980173

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-05
• Study Completion Date: 2017-03-30

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

With Bakri balloon

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

Intervention: Bakri balloon

Group Type: EXPERIMENTAL

Bakri balloon

Intervention Type: DEVICE

Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm will be treated with the immediate placement of a Bakri balloon, followed by routine care if necessary.

Without Bakri balloon

Patients randomized to this arm will receive routine care not including the Bakri Balloon.

Intervention: Routine Care

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: PROCEDURE

Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm of the study will continue to have routine care.

Interventions

Routine care

Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm of the study will continue to have routine care.

Intervention Type: PROCEDURE

Bakri balloon

Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm will be treated with the immediate placement of a Bakri balloon, followed by routine care if necessary.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Letouzey, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU d'Angers - Hôtel-Dieu

Angers, , France

APHP - Hôpital Antoine Beclere

Clamart, , France

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, , France

APHM - Hôpital Nord

Marseille, , France

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, , France

Countries

France

References

Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

Reference Type: DERIVED

PMID: 32609374 (View on PubMed)

Other Identifiers

2013-A00914-41

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/VL-04

Identifier Type: -

Identifier Source: org_study_id