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).

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage

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

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • Moi Teaching and Referral Hospital
  • Kisumu, Kenya
    • Great Lakes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite clinical outcome	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unit of estimated blood loss	Mean and median estimated blood loss	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women with febrile morbidity	febrile morbidity and individual rates of the components of the composite primary outcome	24 hours

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Cook Group Incorporated
• Investigators: Principal Investigator: Haywood Brown, MD, DUHS

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Estimate): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Postpartum hemorrhage; Bakri Postpartum Balloon
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: Pro00029944