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NCT Number: NCT01844089

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

MOI Teaching and Referral Hospital, Eldoret, Kenya

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Unit of estimated blood loss

    Time frame: 24 hours

    Mean and median estimated blood loss

Other outcomes

  1. Number of women with febrile morbidity

    Time frame: 24 hours

    febrile morbidity and individual rates of the components of the composite primary outcome

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Cook Group Incorporated

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 1, 2013
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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