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

Primary Purpose

Postpartum Hemorrhage

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Routine care
Bakri balloon
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Bakri balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • CHU d'Angers - Hôtel-Dieu
  • APHP - Hôpital Antoine Beclere
  • APHP - Centre Hospitalier Universitaire de Bicêtre
  • APHM - Hôpital Nord
  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • CHU de Saint Etienne - Hôpital Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With Bakri balloon

Without Bakri balloon

Arm Description

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

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

Outcomes

Primary Outcome Measures

The % of patients requiring invasive measures for postpartum hemorrhage control.
The total cost (€) associated with the postpartum hemorrhage management strategy.

Secondary Outcome Measures

The delay required to stop bleeding post-delivery (min)
The delay required to stop bleeding post-diagnosis (min)
The percentage of patients still bleeding 30 minutes after sulprostone injection
Blood loss (ml) 30 minutes after diagnosis
Blood loss (ml) 1 hour after diagnosis
Blood loss (ml) 2 hours after diagnosis
Blood loss (ml) 24 hours after diagnosis
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
The % of patients requiring blood transfusion.
The % of patients requiring intravenous iron.
The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed
Fibrinogen (g / l)
Fibrinogen (g / l)
Fibrinogen (g / l)
Hematocrit (%)
Hematocrit (%)
Hematocrit (%)
Hematocrit (%)
Hemoglobin (g/dl)
Hemoglobin (g/dl)
Hemoglobin (g/dl)
Hemoglobin (g/dl)
Prothrombin (%)
Prothrombin (%)
Prothrombin (%)
Prothrombin (%)
Activated partial thromboplastin time (s)
Activated partial thromboplastin time (s)
Activated partial thromboplastin time (s)
Activated partial thromboplastin time (s)
Length of hospital stay (days)
Length of ICU stay
Antimullerian hormone level
Antimullerian hormone level
Amenorrhea at 3 months? yes/no
(Excluding breastfeeding women)
The presence of adhesions detected at hysteroscopy
pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics
pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics
temperature (°C)
FSFI questionnaire (Female Sexual Function Index)
Doppler ultrasound: intrauterine pressure
Doppler ultrasound: thickness of the uterine wall
Doppler ultrasound: inversed diastolic flow
Doppler ultrasound: intraluminal pressure
Doppler ultrasound: uterine artery perfusion pressure
Doppler ultrasound: uterine artery pulsatility index
IES-R scale (symptoms of post-traumatic stress)
Vascular filling required? yes/no
If vascular filling is required, volume and type of solution used.
Were amines required? yes/no

Full Information

First Posted
October 29, 2013
Last Updated
May 4, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01980173
Brief Title
Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Acronym
Bakri
Official Title
Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
September 5, 2014 (Actual)
Primary Completion Date
September 26, 2016 (Actual)
Study Completion Date
March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Bakri balloon

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With Bakri balloon
Arm Type
Experimental
Arm Description
Patients randomized to this arm will be treated using the Bakri balloon. Intervention: Bakri balloon
Arm Title
Without Bakri balloon
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive routine care not including the Bakri Balloon. Intervention: Routine Care
Intervention Type
Procedure
Intervention Name(s)
Routine care
Intervention Description
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
Device
Intervention Name(s)
Bakri balloon
Intervention Description
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.
Primary Outcome Measure Information:
Title
The % of patients requiring invasive measures for postpartum hemorrhage control.
Time Frame
Hospital stay (expected max of 15 days).
Title
The total cost (€) associated with the postpartum hemorrhage management strategy.
Time Frame
Hospital stay (expected max of 15 days).
Secondary Outcome Measure Information:
Title
The delay required to stop bleeding post-delivery (min)
Time Frame
post-partum (expected maximum of a few hours)
Title
The delay required to stop bleeding post-diagnosis (min)
Time Frame
post-partum (expected maximum of a few hours)
Title
The percentage of patients still bleeding 30 minutes after sulprostone injection
Time Frame
30 minutes after sulprostone injection (day 0)
Title
Blood loss (ml) 30 minutes after diagnosis
Time Frame
30 minutes after diagnosis (day 0)
Title
Blood loss (ml) 1 hour after diagnosis
Time Frame
1 hour after diagnosis (day 0)
Title
Blood loss (ml) 2 hours after diagnosis
Time Frame
2 hours after diagnosis (day 0)
Title
Blood loss (ml) 24 hours after diagnosis
Time Frame
24 hours after diagnosis (day 1)
Title
Blood pressure
Time Frame
Upon diagnosis (day 0)
Title
Blood pressure
Time Frame
30 minutes after diagnosis (day 0)
Title
Blood pressure
Time Frame
120 minutes after diagnosis (day 0)
Title
Blood pressure
Time Frame
24 hours after diagnosis (day 1)
Title
Blood pressure
Time Frame
upon sulprostone injection (day 0)
Title
Blood pressure
Time Frame
when placing the Bakri balloon (day 0)
Title
Blood pressure
Time Frame
when performing invasive techniques (expected day 0 or 1)
Title
Heart rate
Time Frame
Upon diagnosis (day 0)
Title
Heart rate
Time Frame
30 minutes after diagnosis (day 0)
Title
Heart rate
Time Frame
120 minutes after diagnosis (day 0)
Title
Heart rate
Time Frame
24 hours after diagnosis (day 1)
Title
Heart rate
Time Frame
upon sulprostone injection (day 0)
Title
Heart rate
Time Frame
when placing the Bakri balloon (day 0)
Title
Heart rate
Time Frame
when performing invasive techniques (expected day 0 or 1)
Title
The % of patients requiring blood transfusion.
Time Frame
Hospital stay (expected max of 15 days).
Title
The % of patients requiring intravenous iron.
Time Frame
Hospital stay (expected max of 15 days).
Title
The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed
Time Frame
Hospital stay (expected max of 15 days).
Title
Fibrinogen (g / l)
Time Frame
Upon diagnosis (day 0)
Title
Fibrinogen (g / l)
Time Frame
Day 1
Title
Fibrinogen (g / l)
Time Frame
Day 3
Title
Hematocrit (%)
Time Frame
Upon diagnosis (day 0)
Title
Hematocrit (%)
Time Frame
Day 1
Title
Hematocrit (%)
Time Frame
Day 3
Title
Hematocrit (%)
Time Frame
the month preceding delivery
Title
Hemoglobin (g/dl)
Time Frame
Upon diagnosis (day 0)
Title
Hemoglobin (g/dl)
Time Frame
Day 1
Title
Hemoglobin (g/dl)
Time Frame
Day 3
Title
Hemoglobin (g/dl)
Time Frame
the month preceding delivery
Title
Prothrombin (%)
Time Frame
the month preceding delivery
Title
Prothrombin (%)
Time Frame
Upon diagnosis (day 0)
Title
Prothrombin (%)
Time Frame
Day 1
Title
Prothrombin (%)
Time Frame
Day 3
Title
Activated partial thromboplastin time (s)
Time Frame
the month preceding delivery
Title
Activated partial thromboplastin time (s)
Time Frame
Upon diagnosis (day 0)
Title
Activated partial thromboplastin time (s)
Time Frame
Day 1
Title
Activated partial thromboplastin time (s)
Time Frame
Day 2
Title
Length of hospital stay (days)
Time Frame
Expected max of 15 days
Title
Length of ICU stay
Time Frame
expected max of 15 days
Title
Antimullerian hormone level
Time Frame
Upon diagnosis (Day 0)
Title
Antimullerian hormone level
Time Frame
2 months after restart of menses
Title
Amenorrhea at 3 months? yes/no
Description
(Excluding breastfeeding women)
Time Frame
3 months
Title
The presence of adhesions detected at hysteroscopy
Time Frame
3 months after delivery if menses have restarted, or 2 months after the restart of menses (maximum of 1 year after inclusion)
Title
pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics
Time Frame
Day 1
Title
pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics
Time Frame
Day 3
Title
temperature (°C)
Time Frame
Daily while in hospital (expected maximum of 15 days)
Title
FSFI questionnaire (Female Sexual Function Index)
Time Frame
6 months
Title
Doppler ultrasound: intrauterine pressure
Time Frame
when placing the Bakri balloon; day 0
Title
Doppler ultrasound: thickness of the uterine wall
Time Frame
when placing the Bakri balloon; day 0
Title
Doppler ultrasound: inversed diastolic flow
Time Frame
when placing the Bakri balloon; day 0
Title
Doppler ultrasound: intraluminal pressure
Time Frame
when placing the Bakri balloon; day 0
Title
Doppler ultrasound: uterine artery perfusion pressure
Time Frame
when placing the Bakri balloon; day 0
Title
Doppler ultrasound: uterine artery pulsatility index
Time Frame
when placing the Bakri balloon; day 0
Title
IES-R scale (symptoms of post-traumatic stress)
Time Frame
6 months
Title
Vascular filling required? yes/no
Time Frame
Day 0
Title
If vascular filling is required, volume and type of solution used.
Time Frame
Day 0
Title
Were amines required? yes/no
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Prophylactic antibiotherapy? yes/no
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Letouzey, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers - Hôtel-Dieu
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
APHP - Hôpital Antoine Beclere
City
Clamart Cedex
ZIP/Postal Code
92141
Country
France
Facility Name
APHP - Centre Hospitalier Universitaire de Bicêtre
City
Le Kremlin Bicêtre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
APHM - Hôpital Nord
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
CHU de Saint Etienne - Hôpital Nord
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32609374
Citation
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.
Results Reference
derived

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

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