Clinical trial NCT01980173: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Official title: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Bakri balloon
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The % of patients requiring invasive measures for postpartum hemorrhage control.
timeFrame: Hospital stay (expected max of 15 days).
measure: The total cost (€) associated with the postpartum hemorrhage management strategy.
timeFrame: Hospital stay (expected max of 15 days).
Secondary outcomes:
measure: The delay required to stop bleeding post-delivery (min)
timeFrame: post-partum (expected maximum of a few hours)
measure: The delay required to stop bleeding post-diagnosis (min)
timeFrame: post-partum (expected maximum of a few hours)
measure: The percentage of patients still bleeding 30 minutes after sulprostone injection
timeFrame: 30 minutes after sulprostone injection (day 0)
measure: Blood loss (ml) 30 minutes after diagnosis
timeFrame: 30 minutes after diagnosis (day 0)
measure: Blood loss (ml) 1 hour after diagnosis
timeFrame: 1 hour after diagnosis (day 0)
measure: Blood loss (ml) 2 hours after diagnosis
timeFrame: 2 hours after diagnosis (day 0)
measure: Blood loss (ml) 24 hours after diagnosis
timeFrame: 24 hours after diagnosis (day 1)
measure: Blood pressure
timeFrame: Upon diagnosis (day 0)
measure: Blood pressure
timeFrame: 30 minutes after diagnosis (day 0)
measure: Blood pressure
timeFrame: 120 minutes after diagnosis (day 0)
measure: Blood pressure
timeFrame: 24 hours after diagnosis (day 1)
measure: Blood pressure
timeFrame: upon sulprostone injection (day 0)
measure: Blood pressure
timeFrame: when placing the Bakri balloon (day 0)
measure: Blood pressure
timeFrame: when performing invasive techniques (expected day 0 or 1)
measure: Heart rate
timeFrame: Upon diagnosis (day 0)
measure: Heart rate
timeFrame: 30 minutes after diagnosis (day 0)
measure: Heart rate
timeFrame: 120 minutes after diagnosis (day 0)
measure: Heart rate
timeFrame: 24 hours after diagnosis (day 1)
measure: Heart rate
timeFrame: upon sulprostone injection (day 0)
measure: Heart rate
timeFrame: when placing the Bakri balloon (day 0)
measure: Heart rate
timeFrame: when performing invasive techniques (expected day 0 or 1)
measure: The % of patients requiring blood transfusion.
timeFrame: Hospital stay (expected max of 15 days).
measure: The % of patients requiring intravenous iron.
timeFrame: Hospital stay (expected max of 15 days).
measure: The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed
timeFrame: Hospital stay (expected max of 15 days).
measure: Fibrinogen (g / l)
timeFrame: Upon diagnosis (day 0)
measure: Fibrinogen (g / l)
timeFrame: Day 1
measure: Fibrinogen (g / l)
timeFrame: Day 3
measure: Hematocrit (%)
timeFrame: Upon diagnosis (day 0)
measure: Hematocrit (%)
timeFrame: Day 1
measure: Hematocrit (%)
timeFrame: Day 3
measure: Hematocrit (%)
timeFrame: the month preceding delivery
measure: Hemoglobin (g/dl)
timeFrame: Upon diagnosis (day 0)
measure: Hemoglobin (g/dl)
timeFrame: Day 1
measure: Hemoglobin (g/dl)
timeFrame: Day 3
measure: Hemoglobin (g/dl)
timeFrame: the month preceding delivery
measure: Prothrombin (%)
timeFrame: the month preceding delivery
measure: Prothrombin (%)
timeFrame: Upon diagnosis (day 0)
measure: Prothrombin (%)
timeFrame: Day 1
measure: Prothrombin (%)
timeFrame: Day 3
measure: Activated partial thromboplastin time (s)
timeFrame: the month preceding delivery
measure: Activated partial thromboplastin time (s)
timeFrame: Upon diagnosis (day 0)
measure: Activated partial thromboplastin time (s)
timeFrame: Day 1
measure: Activated partial thromboplastin time (s)
timeFrame: Day 2
measure: Length of hospital stay (days)
timeFrame: Expected max of 15 days
measure: Length of ICU stay
timeFrame: expected max of 15 days
measure: Antimullerian hormone level
timeFrame: Upon diagnosis (Day 0)
measure: Antimullerian hormone level
timeFrame: 2 months after restart of menses
measure: Amenorrhea at 3 months? yes/no
timeFrame: 3 months
measure: The presence of adhesions detected at hysteroscopy
timeFrame: 3 months after delivery if menses have restarted, or 2 months after the restart of menses (maximum of 1 year after inclusion)
measure: pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics
timeFrame: Day 1
measure: pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics
timeFrame: Day 3
measure: temperature (°C)
timeFrame: Daily while in hospital (expected maximum of 15 days)
measure: FSFI questionnaire (Female Sexual Function Index)
timeFrame: 6 months
measure: Doppler ultrasound: intrauterine pressure
timeFrame: when placing the Bakri balloon; day 0
measure: Doppler ultrasound: thickness of the uterine wall
timeFrame: when placing the Bakri balloon; day 0
measure: Doppler ultrasound: inversed diastolic flow
timeFrame: when placing the Bakri balloon; day 0
measure: Doppler ultrasound: intraluminal pressure
timeFrame: when placing the Bakri balloon; day 0
measure: Doppler ultrasound: uterine artery perfusion pressure
timeFrame: when placing the Bakri balloon; day 0
measure: Doppler ultrasound: uterine artery pulsatility index
timeFrame: when placing the Bakri balloon; day 0
measure: IES-R scale (symptoms of post-traumatic stress)
timeFrame: 6 months
measure: Vascular filling required? yes/no
timeFrame: Day 0
measure: If vascular filling is required, volume and type of solution used.
timeFrame: Day 0
measure: Were amines required? yes/no
timeFrame: Day 0
Other outcomes:
measure: Prophylactic antibiotherapy? yes/no
timeFrame: Day 0
Locations:
city: Angers
country: France
facility: CHU d'Angers - Hôtel-Dieu
city: Clamart Cedex
country: France
facility: APHP - Hôpital Antoine Beclere
city: Le Kremlin Bicêtre Cedex
country: France
facility: APHP - Centre Hospitalier Universitaire de Bicêtre
city: Marseille Cedex 20
country: France
facility: APHM - Hôpital Nord
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Saint-Priest en Jarez
country: France
facility: CHU de Saint Etienne - Hôpital Nord
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.