Status:
COMPLETED
The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures
Lead Sponsor:
Duke University
Collaborating Sponsors:
Cook Group Incorporated
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18+ years
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 managemen...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01844089
Start Date
October 1 2013
End Date
January 1 2015
Last Update
February 16 2015
Active Locations (2)
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1
MOI Teaching and Referral Hospital
Eldoret, Kenya
2
Great Lakes University
Kisumu, Kenya