The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures
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.
- 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).
|Study Design:||Time Perspective: Prospective|
|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)|
- Composite clinical outcome [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
The primary outcome of the study is a composite clinical outcome consisting of:
- Blood transfusion
- Renal failure (creatinine >1.5 mg/dL or increased >1.0 mg/dL above baseline, oliguria <120 ml output in 4 hour intervals)
- Respiratory impairment (impairment of respiratory function requiring ventilation, oxygen supplementation, or decreased physical activity compared to pre-pregnancy levels)
- Central nervous system impairment (seizures, loss of consciousness, or cognitive/motor loss)
- Heart failure (NYHA class III or IV)
- Disseminated intravascular coagulation (DIC) based on clinical and laboratory assessment if available.
- Abdominal surgery to control hemorrhage in non-cesarean patients
- Emergency hysterectomy. Outcomes and definitions are similar to those used in other studies of PPH management in Africa.
- Unit of estimated blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Mean and median estimated blood loss
- Number of women with febrile morbidity [ Time Frame: 24 hours ] [ Designated as safety issue: No ]febrile morbidity and individual rates of the components of the composite primary outcome
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844089
|MOI Teaching and Referral Hospital|
|Great Lakes University|
|Principal Investigator:||Haywood Brown, MD||DUHS|