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

NCT01980173 | Terminated DMC

• 2 other identifiers: LOCAL/2012/VL-042013-A00914-41
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

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

Keywords

Bakri balloon

Outcome Measures

Primary Outcomes (2)

• The % of patients requiring invasive measures for postpartum hemorrhage control.

  Hospital stay (expected max of 15 days).

• The total cost (€) associated with the postpartum hemorrhage management strategy.

  Hospital stay (expected max of 15 days).

Secondary Outcomes (63)

• The delay required to stop bleeding post-delivery (min)

  post-partum (expected maximum of a few hours)

• The delay required to stop bleeding post-diagnosis (min)

  post-partum (expected maximum of a few hours)

• The percentage of patients still bleeding 30 minutes after sulprostone injection

  30 minutes after sulprostone injection (day 0)

• Blood loss (ml) 30 minutes after diagnosis

  30 minutes after diagnosis (day 0)

• Blood loss (ml) 1 hour after diagnosis

  1 hour after diagnosis (day 0)

Other Outcomes (1)

• Prophylactic antibiotherapy? yes/no

  Day 0

Study Arms (2)

With Bakri balloon

EXPERIMENTAL

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

Device: Bakri balloon

Without Bakri balloon

ACTIVE COMPARATOR

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

Procedure: Routine care

Interventions

Routine care 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.

Without Bakri balloon

Bakri balloon 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.

With Bakri balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (7)

CHU d'Angers - Hôtel-Dieu

Angers, 49933, France

Location

APHP - Hôpital Antoine Beclere

Clamart, 92141, France

Location

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (1)

• 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.

  PMID: 32609374 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Letouzey, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 8, 2013
• Study Start: September 5, 2014
• Primary Completion: September 26, 2016
• Study Completion: March 30, 2017
• Last Updated: May 11, 2018

Record last verified: 2016-09

Locations

FR (7)