BleedingBB-ATSNCT02694341
Bakri Balloon in Placenta Previa
A study testing Abdominal traction stitch and Bakri Balloon in people with Bleeding and Placenta Previa, run by Assiut University at 1 site in Egypt.
Trial summary
The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Bleeding, Placenta Previa
- What is being tested?
- Abdominal traction stitch and Bakri Balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2018to Dec 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women delivered and presented with primary atonic PPH
- Women who accepted to participate
Who cannot join
- Traumatic PPH as excluded by examination under anesthesia.
- With any suspected or clinical evidence of uterine infection
- Women diagnosed to have preeclampsia or eclampsia after delivery.
- Women who had DM during pregnancy
- Women with history of DVT or other thromboembolic complication
- Women with history of rheumatic heart disease.
- Women with coagulation defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.
- Conditions
- Bleeding, Placenta Previa
- Being tested
- Abdominal traction stitch, Bakri Balloon
- Keywords
- Management
- Medical subject headings
- Hemorrhage, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal traction stitchProcedure or surgery
Abdominal traction stitch to prevent prolapse of the Bakri balloon. A suture is tied through the uterine end shaft hole of the Bakri balloon. The other end of the suture is placed through the uterine wall. The balloon is positioned in the lower segment.The abdominal traction stitch is held by forceps and fixed, with cephalad traction applied continuously to the balloon, preventing balloon prolapse.The abdominal traction stitch is fixed by an umbilical cord clamp on the abdominal wall, preventing the suture from receding into the abdominal cavity, and, thus, maintaining the correct position of the balloon and preventing prolapse. Removal of the balloon is easy, with no resistance; the suture does not hinder balloon removal. At the time of balloon removal, the suture that was placed through the abdominal wall will traverse the intra-abdominal and intrauterine cavities, and should be kept clean.
Bakri BalloonDevice
uterine compression balloon
| Study group | Role | What they receive |
|---|---|---|
| Bakri Balloon with abdominal traction stitch | Active comparator | bakri balloon will be inserted with abdominal traction stitch Receives: Procedure: Abdominal traction stitch; Device: Bakri Balloon |
| Bakri Balloon without abdominal traction stitch | Experimental | bakri balloon will be inserted with no performance of abdominal traction stitch Receives: Device: Bakri Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
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 posted29 Feb 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: No participants shared
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 BleedingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694341
- Sponsor's protocol ID
- BB
- Acronym
- BB-ATS
- Status last verified
- May 2020
- First submitted
- 24 Feb 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
- ClinicalTrials.gov ID
- NCT02694341
- Acronym / sponsor ID
- BB-ATS / BB
- Conditions
- Bleeding, Placenta Previa
- Keywords
- Management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants shared
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Feb 2016 (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 Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bakri Balloon with abdominal traction stitch | Active comparator | Procedure: Abdominal traction stitch, Device: Bakri Balloonbakri balloon will be inserted with abdominal traction stitch |
| Bakri Balloon without abdominal traction stitch | Experimental | Device: Bakri Balloonbakri balloon will be inserted with no performance of abdominal traction stitch |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All women delivered and presented with primary atonic PPH
- Women who accepted to participate
Key exclusion criteria (7 listed)
- Traumatic PPH as excluded by examination under anesthesia.
- With any suspected or clinical evidence of uterine infection
- Women diagnosed to have preeclampsia or eclampsia after delivery.
- Women who had DM during pregnancy
- Women with history of DVT or other thromboembolic complication
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 |
|---|---|---|
| Abdominal traction stitchAbdominal traction stitch to prevent prolapse of the Bakri balloon. A suture is tied through the uterine end shaft hole of the Bakri balloon. The other end of the suture is placed through the uterine wall. The balloon is positioned in the lower segment.The abdominal traction stitch is held by forceps and fixed, with cephalad traction applied continuously to the balloon, preventing balloon prolapse.The abdominal traction stitch is fixed by an umbilical cord clamp on the abdominal wall, preventing the suture from receding into the abdominal cavity, and, thus, maintaining the correct position of the balloon and preventing prolapse. Removal of the balloon is easy, with no resistance; the suture does not hinder balloon removal. At the time of balloon removal, the suture that was placed through the abdominal wall will traverse the intra-abdominal and intrauterine cavities, and should be kept clean. | Procedure or surgery | Bakri Balloon with abdominal traction stitch |
| Bakri Balloonuterine compression balloon | Device | Bakri Balloon with abdominal traction stitch, Bakri Balloon without abdominal traction stitch |
Primary outcome
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal traction stitch and Bakri Balloon in people with Bleeding and Placenta Previa, run by Assiut University at 1 site in Egypt.
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 7 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: withdrawn, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon. (time frame: 24 hours). 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 NCT02694341, 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 28 May 2020.