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

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.

Study Overview

• Status: Terminated
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: Bakri balloon; Procedure: Routine care

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers - Hôtel-Dieu
  • Clamart Cedex, France, 92141
    • APHP - Hôpital Antoine Béclère
  • Le Kremlin Bicêtre Cedex, France, 94275
    • APHP - Centre Hospitalier Universitaire de Bicêtre
  • Marseille Cedex 20, France, 13915
    • Aphm - Hopital Nord
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hopital Arnaud de Villeneuve
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Saint-Priest en Jarez, France, 42270
    • CHU de Saint Etienne - Hôpital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With Bakri balloon; Patients randomized to this arm will be treated using the Bakri balloon. Intervention: Bakri balloon	Device: 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.
Active Comparator: Without Bakri balloon; Patients randomized to this arm will receive routine care not including the Bakri Balloon. Intervention: Routine Care	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Blood loss (ml) 2 hours after diagnosis		2 hours after diagnosis (day 0)
Blood loss (ml) 24 hours after diagnosis		24 hours after diagnosis (day 1)
Blood pressure		Upon diagnosis (day 0)
Blood pressure		30 minutes after diagnosis (day 0)
Blood pressure		120 minutes after diagnosis (day 0)
Blood pressure		24 hours after diagnosis (day 1)
Blood pressure		upon sulprostone injection (day 0)
Blood pressure		when placing the Bakri balloon (day 0)
Blood pressure		when performing invasive techniques (expected day 0 or 1)
Heart rate		Upon diagnosis (day 0)
Heart rate		30 minutes after diagnosis (day 0)
Heart rate		120 minutes after diagnosis (day 0)
Heart rate		24 hours after diagnosis (day 1)
Heart rate		upon sulprostone injection (day 0)
Heart rate		when placing the Bakri balloon (day 0)
Heart rate		when performing invasive techniques (expected day 0 or 1)
The % of patients requiring blood transfusion.		Hospital stay (expected max of 15 days).
The % of patients requiring intravenous iron.		Hospital stay (expected max of 15 days).
The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed		Hospital stay (expected max of 15 days).
Fibrinogen (g / l)		Upon diagnosis (day 0)
Fibrinogen (g / l)		Day 1
Fibrinogen (g / l)		Day 3
Hematocrit (%)		Upon diagnosis (day 0)
Hematocrit (%)		Day 1
Hematocrit (%)		Day 3
Hematocrit (%)		the month preceding delivery
Hemoglobin (g/dl)		Upon diagnosis (day 0)
Hemoglobin (g/dl)		Day 1
Hemoglobin (g/dl)		Day 3
Hemoglobin (g/dl)		the month preceding delivery
Prothrombin (%)		the month preceding delivery
Prothrombin (%)		Upon diagnosis (day 0)
Prothrombin (%)		Day 1
Prothrombin (%)		Day 3
Activated partial thromboplastin time (s)		the month preceding delivery
Activated partial thromboplastin time (s)		Upon diagnosis (day 0)
Activated partial thromboplastin time (s)		Day 1
Activated partial thromboplastin time (s)		Day 2
Length of hospital stay (days)		Expected max of 15 days
Length of ICU stay		expected max of 15 days
Antimullerian hormone level		Upon diagnosis (Day 0)
Antimullerian hormone level		2 months after restart of menses
Amenorrhea at 3 months? yes/no	(Excluding breastfeeding women)	3 months
The presence of adhesions detected at hysteroscopy		3 months after delivery if menses have restarted, or 2 months after the restart of menses (maximum of 1 year after inclusion)
pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics		Day 1
pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics		Day 3
temperature (°C)		Daily while in hospital (expected maximum of 15 days)
FSFI questionnaire (Female Sexual Function Index)		6 months
Doppler ultrasound: intrauterine pressure		when placing the Bakri balloon; day 0
Doppler ultrasound: thickness of the uterine wall		when placing the Bakri balloon; day 0
Doppler ultrasound: inversed diastolic flow		when placing the Bakri balloon; day 0
Doppler ultrasound: intraluminal pressure		when placing the Bakri balloon; day 0
Doppler ultrasound: uterine artery perfusion pressure		when placing the Bakri balloon; day 0
Doppler ultrasound: uterine artery pulsatility index		when placing the Bakri balloon; day 0
IES-R scale (symptoms of post-traumatic stress)		6 months
Vascular filling required? yes/no		Day 0
If vascular filling is required, volume and type of solution used.		Day 0
Were amines required? yes/no		Day 0

Other Outcome Measures

Outcome Measure	Time Frame
Prophylactic antibiotherapy? yes/no	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2014
• Primary Completion (Actual): September 26, 2016
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Bakri balloon
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: LOCAL/2012/VL-04; 2013-A00914-41 (Other Identifier: RCB number)