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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Procedure: Routine care
* Device: Bakri balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bakri balloon