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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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


Sponsor: Duke University

Current Primary Outcome: Composite clinical outcome [ Time Frame: 24 hours ]

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.


Original Primary Outcome: Composite clinical outcome [ Time Frame: 24 hours ]

The primary coutcome 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.


Current Secondary Outcome: Unit of estimated blood loss [ Time Frame: 24 hours ]

Mean and median estimated blood loss


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: April 29, 2013
Date Started: October 2013
Date Completion:
Last Updated: February 12, 2015
Last Verified: February 2015