Postpartum HemorrhageNCT01844089
The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures
An observational study of Postpartum Hemorrhage, run by Duke University at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- How many people
- 57 participants
- Where
- 2 sitesKenya
- Study dates
- Oct 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage.
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
MOI Teaching and Referral Hospital
Eldoret
Great Lakes University
Kisumu
About this study
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)
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).
Read the 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
- Keywords
- Postpartum hemorrhage, Bakri Postpartum Balloon
- Medical subject headings
- Postpartum Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
Unit of estimated blood loss
Mean and median estimated blood loss
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Group Incorporated
- Responsible party
- Sponsor
- Investigators
- Haywood Brown, MD, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844089
- Sponsor's protocol ID
- Pro00029944
- Status last verified
- Feb 2015
- First submitted
- 29 Apr 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01844089
- Acronym / sponsor ID
- Pro00029944
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Bakri Postpartum Balloon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Cook Group Incorporated
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Unit of estimated blood loss
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
Related trials for Postpartum Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haywood Brown, MD principal investigator
DUHS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Duke University at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical outcome (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.