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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00914-41 | Other Identifier | RCB number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Bakri balloon | Experimental | Patients randomized to this arm will be treated using the Bakri balloon. Intervention: Bakri balloon |
|
| Without Bakri balloon | Active Comparator | Patients randomized to this arm will receive routine care not including the Bakri Balloon. Intervention: Routine Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Prophylactic antibiotherapy? yes/no | Day 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers - Hôtel-Dieu | Angers | 49933 | France | |||
| APHP - Hôpital Antoine Beclere |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32609374 | Derived | 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. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| 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. |
|
| 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 |
| Clamart |
| 92141 |
| France |
| APHP - Centre Hospitalier Universitaire de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| APHM - Hôpital Nord | Marseille | 13915 | France |
| CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| CHU de Saint Etienne - Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |