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

Postpartum Hemorrhage Clinical Trial

— Bakri  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01980173
• Other study ID #: LOCAL/2012/VL-04
• Secondary ID: 2013-A00914-41
• Status: Terminated
• Phase: N/A
• Start date: September 5, 2014
• Est. completion date: March 30, 2017

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: March 30, 2017
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• 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.

Device:
• Bakri balloon
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.

Locations

Country	Name	City	State
France	CHU d'Angers - Hôtel-Dieu	Angers
France	APHP - Hôpital Antoine Beclere	Clamart Cedex
France	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex
France	APHM - Hôpital Nord	Marseille Cedex 20
France	CHRU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9
France	CHU de Saint Etienne - Hôpital Nord	Saint-Priest en Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prophylactic antibiotherapy? yes/no		Day 0
Primary	The % of patients requiring invasive measures for postpartum hemorrhage control.		Hospital stay (expected max of 15 days).
Primary	The total cost (€) associated with the postpartum hemorrhage management strategy.		Hospital stay (expected max of 15 days).
Secondary	The delay required to stop bleeding post-delivery (min)		post-partum (expected maximum of a few hours)
Secondary	The delay required to stop bleeding post-diagnosis (min)		post-partum (expected maximum of a few hours)
Secondary	The percentage of patients still bleeding 30 minutes after sulprostone injection		30 minutes after sulprostone injection (day 0)
Secondary	Blood loss (ml) 30 minutes after diagnosis		30 minutes after diagnosis (day 0)
Secondary	Blood loss (ml) 1 hour after diagnosis		1 hour after diagnosis (day 0)
Secondary	Blood loss (ml) 2 hours after diagnosis		2 hours after diagnosis (day 0)
Secondary	Blood loss (ml) 24 hours after diagnosis		24 hours after diagnosis (day 1)
Secondary	Blood pressure		Upon diagnosis (day 0)
Secondary	Blood pressure		30 minutes after diagnosis (day 0)
Secondary	Blood pressure		120 minutes after diagnosis (day 0)
Secondary	Blood pressure		24 hours after diagnosis (day 1)
Secondary	Blood pressure		upon sulprostone injection (day 0)
Secondary	Blood pressure		when placing the Bakri balloon (day 0)
Secondary	Blood pressure		when performing invasive techniques (expected day 0 or 1)
Secondary	Heart rate		Upon diagnosis (day 0)
Secondary	Heart rate		30 minutes after diagnosis (day 0)
Secondary	Heart rate		120 minutes after diagnosis (day 0)
Secondary	Heart rate		24 hours after diagnosis (day 1)
Secondary	Heart rate		upon sulprostone injection (day 0)
Secondary	Heart rate		when placing the Bakri balloon (day 0)
Secondary	Heart rate		when performing invasive techniques (expected day 0 or 1)
Secondary	The % of patients requiring blood transfusion.		Hospital stay (expected max of 15 days).
Secondary	The % of patients requiring intravenous iron.		Hospital stay (expected max of 15 days).
Secondary	The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed		Hospital stay (expected max of 15 days).
Secondary	Fibrinogen (g / l)		Upon diagnosis (day 0)
Secondary	Fibrinogen (g / l)		Day 1
Secondary	Fibrinogen (g / l)		Day 3
Secondary	Hematocrit (%)		Upon diagnosis (day 0)
Secondary	Hematocrit (%)		Day 1
Secondary	Hematocrit (%)		Day 3
Secondary	Hematocrit (%)		the month preceding delivery
Secondary	Hemoglobin (g/dl)		Upon diagnosis (day 0)
Secondary	Hemoglobin (g/dl)		Day 1
Secondary	Hemoglobin (g/dl)		Day 3
Secondary	Hemoglobin (g/dl)		the month preceding delivery
Secondary	Prothrombin (%)		the month preceding delivery
Secondary	Prothrombin (%)		Upon diagnosis (day 0)
Secondary	Prothrombin (%)		Day 1
Secondary	Prothrombin (%)		Day 3
Secondary	Activated partial thromboplastin time (s)		the month preceding delivery
Secondary	Activated partial thromboplastin time (s)		Upon diagnosis (day 0)
Secondary	Activated partial thromboplastin time (s)		Day 1
Secondary	Activated partial thromboplastin time (s)		Day 2
Secondary	Length of hospital stay (days)		Expected max of 15 days
Secondary	Length of ICU stay		expected max of 15 days
Secondary	Antimullerian hormone level		Upon diagnosis (Day 0)
Secondary	Antimullerian hormone level		2 months after restart of menses
Secondary	Amenorrhea at 3 months? yes/no	(Excluding breastfeeding women)	3 months
Secondary	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)
Secondary	pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics		Day 1
Secondary	pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics		Day 3
Secondary	temperature (°C)		Daily while in hospital (expected maximum of 15 days)
Secondary	FSFI questionnaire (Female Sexual Function Index)		6 months
Secondary	Doppler ultrasound: intrauterine pressure		when placing the Bakri balloon; day 0
Secondary	Doppler ultrasound: thickness of the uterine wall		when placing the Bakri balloon; day 0
Secondary	Doppler ultrasound: inversed diastolic flow		when placing the Bakri balloon; day 0
Secondary	Doppler ultrasound: intraluminal pressure		when placing the Bakri balloon; day 0
Secondary	Doppler ultrasound: uterine artery perfusion pressure		when placing the Bakri balloon; day 0
Secondary	Doppler ultrasound: uterine artery pulsatility index		when placing the Bakri balloon; day 0
Secondary	IES-R scale (symptoms of post-traumatic stress)		6 months
Secondary	Vascular filling required? yes/no		Day 0
Secondary	If vascular filling is required, volume and type of solution used.		Day 0
Secondary	Were amines required? yes/no		Day 0