Postpartum HemorrhageNCT02568657
Uterine Tamponade for Treatment of Primary Postpartum Hemorrhage
A study testing Celox group and Bakri Balloon in people with Postpartum Hemorrhage, run by Assiut University.
Trial summary
Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries. Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Celox group and Bakri Balloon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Oct 2015
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who accept to participate (either the patient or her first-kin if she is unconscious)
- Primary atonic postpartum hemorrhage
Who cannot join
- 1. Traumatic postpartum haemorrhage
About this study
Official title: Comparison Between Celox Versus Bakri Balloon for Treatment of Primary Atonic Postpartum Hemorrhage
Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.
Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should be considered a PPH.
Read more
In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.
In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.
The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings.
One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox.
Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin .
Read the detailed description
Balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings.
One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox.
Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin.
We will be having two groups:
- Celox group: Celox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours.
- Bakri balloon group:
Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Celox group, Bakri Balloon
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celox groupDevice
Bakri BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Celox group | Active comparator | Celox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours. Receives: Device: Celox group |
| Bakri balloon group | Active comparator | Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe. Receives: Device: Bakri Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss (mL)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568657
- Sponsor's protocol ID
- Celox
- Status last verified
- Aug 2020
- First submitted
- 4 Oct 2015
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
PubMed 32609374
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Celox Versus Bakri Balloon for Treatment of Primary Atonic Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT02568657
- Acronym / sponsor ID
- Celox
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Oct 2015 (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.
Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.
Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should be considered a PPH.
In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.
In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.
The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings.
One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox.
Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin .
Detailed description
Balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings.
One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox.
Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin.
We will be having two groups:
- Celox group: Celox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours.
- Bakri balloon group:
Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celox group | Active comparator | Device: Celox groupCelox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours. |
| Bakri balloon group | Active comparator | Device: Bakri BalloonBefore insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who accept to participate (either the patient or her first-kin if she is unconscious)
- Primary atonic postpartum hemorrhage
Key exclusion criteria (1 listed)
- 1. Traumatic postpartum haemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celox group | Device | Celox group |
| Bakri Balloon | Device | Bakri balloon group |
Primary outcome
Amount of blood loss (mL)
Time frame: 8 months
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 12 Aug 2020.
- Derived from this study: PubMed 32609374Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Celox group and Bakri Balloon in people with Postpartum Hemorrhage, run by Assiut University.
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 2 inclusion and 1 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Amount of blood loss (mL) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568657, which also lists 1 linked publication.
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 12 Aug 2020.