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

N/ATerminatedNCT01980173

Centre Hospitalier Universitaire de Nīmes26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Postpartum Hemorrhage

Interventions

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.

Bakri balloonDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

CHU d'Angers - Hôtel-Dieu

Angers, France

APHP - Hôpital Antoine Beclere

Clamart, France

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, France

APHM - Hôpital Nord

Marseille, France

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, France

Outcomes

Primary Outcomes

The % of patients requiring invasive measures for postpartum hemorrhage control.

Time frame: Hospital stay (expected max of 15 days).

The total cost (€) associated with the postpartum hemorrhage management strategy.

Time frame: Hospital stay (expected max of 15 days).

Secondary Outcomes

The delay required to stop bleeding post-delivery (min)

Time frame: post-partum (expected maximum of a few hours)

The delay required to stop bleeding post-diagnosis (min)

Time frame: post-partum (expected maximum of a few hours)

The percentage of patients still bleeding 30 minutes after sulprostone injection

Time frame: 30 minutes after sulprostone injection (day 0)

Blood loss (ml) 30 minutes after diagnosis

Time frame: 30 minutes after diagnosis (day 0)

Blood loss (ml) 1 hour after diagnosis

Time frame: 1 hour after diagnosis (day 0)

Blood loss (ml) 2 hours after diagnosis

Time frame: 2 hours after diagnosis (day 0)

Blood loss (ml) 24 hours after diagnosis

Time frame: 24 hours after diagnosis (day 1)

Blood pressure

Time frame: Upon diagnosis (day 0)

Blood pressure

Time frame: 30 minutes after diagnosis (day 0)

Blood pressure

Time frame: 120 minutes after diagnosis (day 0)

Blood pressure

Time frame: 24 hours after diagnosis (day 1)

Blood pressure

Time frame: upon sulprostone injection (day 0)

Blood pressure

Time frame: when placing the Bakri balloon (day 0)

Blood pressure

Time frame: when performing invasive techniques (expected day 0 or 1)

Heart rate

Time frame: Upon diagnosis (day 0)

Heart rate

Time frame: 30 minutes after diagnosis (day 0)

Heart rate

Time frame: 120 minutes after diagnosis (day 0)

Heart rate

Time frame: 24 hours after diagnosis (day 1)

Heart rate

Time frame: upon sulprostone injection (day 0)

Heart rate

Time frame: when placing the Bakri balloon (day 0)

Heart rate

Time frame: when performing invasive techniques (expected day 0 or 1)

The % of patients requiring blood transfusion.

Time frame: Hospital stay (expected max of 15 days).

The % of patients requiring intravenous iron.

Time frame: Hospital stay (expected max of 15 days).

The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed

Time frame: Hospital stay (expected max of 15 days).

Fibrinogen (g / l)

Time frame: Upon diagnosis (day 0)

Fibrinogen (g / l)

Time frame: Day 1

Fibrinogen (g / l)

Time frame: Day 3

Hematocrit (%)

Time frame: Upon diagnosis (day 0)

Hematocrit (%)

Time frame: Day 1

Hematocrit (%)

Time frame: Day 3

Hematocrit (%)

Time frame: the month preceding delivery

Hemoglobin (g/dl)

Time frame: Upon diagnosis (day 0)

Hemoglobin (g/dl)

Time frame: Day 1

Hemoglobin (g/dl)

Time frame: Day 3

Hemoglobin (g/dl)

Time frame: the month preceding delivery

Prothrombin (%)

Time frame: the month preceding delivery

Prothrombin (%)

Time frame: Upon diagnosis (day 0)

Prothrombin (%)

Time frame: Day 1

Prothrombin (%)

Time frame: Day 3

Activated partial thromboplastin time (s)

Time frame: the month preceding delivery

Activated partial thromboplastin time (s)

Time frame: Upon diagnosis (day 0)

Activated partial thromboplastin time (s)

Time frame: Day 1

Activated partial thromboplastin time (s)

Time frame: Day 2

Length of hospital stay (days)

Time frame: Expected max of 15 days

Length of ICU stay

Time frame: expected max of 15 days

Antimullerian hormone level

Time frame: Upon diagnosis (Day 0)

Antimullerian hormone level

Time frame: 2 months after restart of menses

Amenorrhea at 3 months? yes/no

(Excluding breastfeeding women)

Time frame: 3 months

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)

pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics

Time frame: Day 1

pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics

Time frame: Day 3

temperature (°C)

Time frame: Daily while in hospital (expected maximum of 15 days)

FSFI questionnaire (Female Sexual Function Index)

Time frame: 6 months

Doppler ultrasound: intrauterine pressure

Time frame: when placing the Bakri balloon; day 0

Doppler ultrasound: thickness of the uterine wall

Time frame: when placing the Bakri balloon; day 0

Doppler ultrasound: inversed diastolic flow

Time frame: when placing the Bakri balloon; day 0

Doppler ultrasound: intraluminal pressure

Time frame: when placing the Bakri balloon; day 0

Doppler ultrasound: uterine artery perfusion pressure

Time frame: when placing the Bakri balloon; day 0

Doppler ultrasound: uterine artery pulsatility index

Time frame: when placing the Bakri balloon; day 0

IES-R scale (symptoms of post-traumatic stress)

Time frame: 6 months

Vascular filling required? yes/no

Time frame: Day 0

If vascular filling is required, volume and type of solution used.

Time frame: Day 0

Were amines required? yes/no

Time frame: Day 0