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

NCT ID: NCT01844089

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-01-31

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 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

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haywood Brown, MD

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

MOI Teaching and Referral Hospital

Eldoret, , Kenya

Great Lakes University

Kisumu, , Kenya

Countries

Kenya

Other Identifiers

Pro00029944

Identifier Type: -

Identifier Source: org_study_id