NCT01844089

The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Postpartum Hemorrhage

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-05-01
• Last updated: 2015-02-16

Locations

2 sites across 1 country: Kenya