Clinical trial NCT01844089: The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures
Official title: The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures: A Multi-Site Longitudinal Study An Initiative Under the East African Women's Health Network (EAWoHNet)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Bakri Postpartum Balloon
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Cook Group Incorporated
First posted: 2013-05-01
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage.

Brief summary: The broad objective of the study is to determine if the Bakri Postpartum Balloon is effective in preventing morbidity and mortality from postpartum hemorrhage (PPH) as part of a standardized management algorithm.

Specific Objectives

* To estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of a standardized protocol for management of PPH, but prior to the inclusion of the Bakri Postpartum Balloon as part of the protocol.
* To estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of a standardized protocol for management of PPH, after the inclusion of the Bakri Postpartum Balloon as part of the protocol.
* To compare morbidity
* To generate preliminary data for (a) a larger confirmatory study of the use of the Bakri Postpartum Balloon in centers with surgical and blood transfusion services, and (b) design of a pilot study of the use of the Bakri device of temporary control of PPH in settings outside of surgical centers (such as by trained midwives or emergency transport personnel).

Detailed description: Phase I: Development and training of staff in standardized algorithm for management of PPH using available local resources (not including Bakri balloon).

Phase II: Data collection after introduction of the standardized algorithm.

Phase III: Revision of protocol to include the Bakri Postpartum Device

Phase IV: Data collection after introduction of the Bakri device

Bakri Postpartum Balloon 510K Premarket Notification/Cook OBGYN #K062438

Eligibility criteria: Inclusion Criteria:

* Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage, defined as
* Clinically estimated blood loss of greater than 500 ml for a vaginal delivery, or
* Clinically estimated blood loss of greater than 1000 ml for a cesarean delivery, or
* Hemodynamic changes that, in the opinion of the care team, require interventions beyond routine postpartum or postdelivery care (such as intravenous fluids or the use of more than one uterotonic agent).

Exclusion Criteria:

* Minors (less than 18 years of age)
* Arterial bleeding requiring surgical exploration or angiographic embolization
* Cases requiring immediate lifesaving hysterectomy
* Ongoing intrauterine pregnancy
* Cervical cancer
* Purulent infections of the vagina, cervix or uterus
* Untreated uterine anomaly
* Disseminated intravascular coagulation
* A surgical site which would prohibit the device from effectively controlling bleeding
* Patients who are referred for obstructed labor
* Patients with signs, symptoms or other evidence of ruptured uterus

Primary outcomes:
measure: Composite clinical outcome
timeFrame: 24 hours
Secondary outcomes:
measure: Unit of estimated blood loss
timeFrame: 24 hours
Other outcomes:
measure: Number of women with febrile morbidity
timeFrame: 24 hours
Locations:
city: Eldoret
country: Kenya
facility: MOI Teaching and Referral Hospital
city: Kisumu
country: Kenya
facility: Great Lakes University
Study officials:
affiliation: DUHS
name: Haywood Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: