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

NCT01844089 | Completed DMC

• 1 other identifier: Pro00029944
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 2

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).

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage; Bakri Postpartum Balloon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Unit of estimated blood loss

  24 hours

Other Outcomes (1)

• Number of women with febrile morbidity

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Cook Group Incorporated: collaborator

Study Sites (2)

MOI Teaching and Referral Hospital

Eldoret, Kenya

Location

Great Lakes University

Kisumu, Kenya

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Haywood Brown, MD

  DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

KE (2)