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

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ClinicalTrials.gov Identifier: NCT01844089
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : February 16, 2015
Sponsor:
Collaborator:
Cook Group Incorporated
Information provided by (Responsible Party):
Duke University

April 29, 2013
May 1, 2013
February 16, 2015
October 2013
January 2015   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01844089 on ClinicalTrials.gov Archive Site
Unit of estimated blood loss [ Time Frame: 24 hours ]
Mean and median estimated blood loss
Same as current
Number of women with febrile morbidity [ Time Frame: 24 hours ]
febrile morbidity and individual rates of the components of the composite primary outcome
Same as current
 
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)

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).

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage.
Postpartum Hemorrhage
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
70
January 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
 
NCT01844089
Pro00029944
Yes
Not Provided
Not Provided
Duke University
Duke University
Cook Group Incorporated
Principal Investigator: Haywood Brown, MD DUHS
Duke University
February 2015