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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cook
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01844089
First received: April 29, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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).

Condition
Postpartum Hemorrhage

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Unit of estimated blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Mean and median estimated blood loss


Other Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: October 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844089

Locations
Kenya
MOI Teaching and Referral Hospital
Eldoret, Kenya
Great Lakes University
Kisumu, Kenya
Sponsors and Collaborators
Duke University
Cook
Investigators
Principal Investigator: Haywood Brown, MD DUHS
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01844089     History of Changes
Other Study ID Numbers: Pro00029944
Study First Received: April 29, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board
Kenya: IREC and GERC

Keywords provided by Duke University:
Postpartum hemorrhage
Bakri Postpartum Balloon

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage

ClinicalTrials.gov processed this record on September 15, 2014