Blood Loss, SurgicalNCT06359886
B-lynch Transverse Compression Suture
A study testing B-Lynch Transverse Compression Suture in people with Blood Loss, Surgical, run by Alexandria University at 1 site in Egypt.
Trial summary
Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa? Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- B-Lynch Transverse Compression Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to Sep 2025
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Single gestation
- Elective CS for placenta preiva (diagnosed by transvaginal ultrasound).
- Muliparity (para 2 or more).
Who cannot join
- Morbidly adherent placenta: accrete, increta or percreta, diagnosed by abdominal and/or transvaginal ultrasound.
- Ultrasonographic features of morbidly adherent placentas:
- Loss of Retro-placental sonolucent zone.
- Vascular lacunae.
- Myometrial thinning.
- Interruption of the bladder border.
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- More than 3 previous C.S.
- Severely haemodynamic instablility needing immediate hysterectomy.
- Patients with the cardiac, hepatic, renal or thromboembolic disease
- Patients with coagulopathy:
- Receiving anticoagulant therapy.
- With thrombocytopenia or thrombasthenia.
- Known coagulation factor defect.
- Distorted uterus as unicornuate, bicornuate, fibroid uterus and adenomyosis uteri.
Trial locations and contacts
1 site in 1 country.
Asmaa F Kassem, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 21526
Ahmed S Zeerban, Msc, +201003119968, Ahmedzeerban@gmail.com
About this study
Official title: B-lynch Transverse Compression Suture in the Prophylaxis and Control of Postpartum Heamorrhage in Patients With Placenta Previa: A Pilot Study
Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa?
Read the detailed description
To perform B-Lynch Transverse Compression Suture the investigators will use the suture material 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms suture. the investigators will use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle.
The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 1-3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side.
After encircling the para-uterine vasculature, the needle then perforates the posterior side of the uterus behind the vascular bundle entering the uterine cavity 1-3 cm below the inferior margin of the Caesarean incision. The suture can lie freely on the posterior wall of the uterine cavity and exists 3 cms above the upper margin of the Caesarean incision. It exits posteriorly and behind the vascular bundle to meet the suture from the other side.
It is essential that the ureters are identified by palpation or visual observation after the bladder is displaced inferiorly and held by traction. Any observed bleeding should be dealt with in the usual way. At the end of the suture application and before tying the knots, the lower segment is compressed again transversely whilst the suture is held taut to ensure that bleeding has ceased by swabbing the vagina again.
A wide pore drain will be inserted in the Douglas pouch, and the abdominal wall will be repaired.
- Conditions
- Blood Loss, Surgical
- Being tested
- B-Lynch Transverse Compression Suture
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Lynch Transverse Compression SutureProcedure or surgery
Also called B-Lynch Transverse Compression Suture using 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms suture
closure of uterine and utero ovarian arteries bilaterally with one suture
| Study group | Role | What they receive |
|---|---|---|
| B-Lynch Transverse Compression Suture | Experimental | Transverse B-Lynch suture will be performed to these patients as a method of controlling postpartum heamorrhage in placenta previa patients Receives: Procedure: B-Lynch Transverse Compression Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Number of towels and blood in suction reservoir
Measured: 2 days following the procedure
Postoperative blood loss
Postoperative blood loss in the drain bag
Measured: 2 days following the procedure
Number of received blood components
Packed RBC's
Measured: 2 days following the procedure
Peripartum haemoglobin level drop
Difference between pre and postoperative hemoglobin level
Measured: 2 days following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start20 Mar 2024
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Pilot Study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zeerban, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359886
- Sponsor's protocol ID
- FMASU MD 292/2022
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical data discussion conclusion
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-lynch Transverse Compression Suture in the Prophylaxis and Control of Postpartum Heamorrhage in Patients With Placenta Previa: A Pilot Study
- ClinicalTrials.gov ID
- NCT06359886
- Acronym / sponsor ID
- FMASU MD 292/2022
- Conditions
- Blood Loss, Surgical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- 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.
Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa?
Detailed description
To perform B-Lynch Transverse Compression Suture the investigators will use the suture material 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms suture. the investigators will use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle.
The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 1-3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side.
After encircling the para-uterine vasculature, the needle then perforates the posterior side of the uterus behind the vascular bundle entering the uterine cavity 1-3 cm below the inferior margin of the Caesarean incision. The suture can lie freely on the posterior wall of the uterine cavity and exists 3 cms above the upper margin of the Caesarean incision. It exits posteriorly and behind the vascular bundle to meet the suture from the other side.
It is essential that the ureters are identified by palpation or visual observation after the bladder is displaced inferiorly and held by traction. Any observed bleeding should be dealt with in the usual way. At the end of the suture application and before tying the knots, the lower segment is compressed again transversely whilst the suture is held taut to ensure that bleeding has ceased by swabbing the vagina again.
A wide pore drain will be inserted in the Douglas pouch, and the abdominal wall will be repaired.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Pilot Study
| Arm | Type | Receives |
|---|---|---|
| B-Lynch Transverse Compression Suture | Experimental | Procedure: B-Lynch Transverse Compression SutureTransverse B-Lynch suture will be performed to these patients as a method of controlling postpartum heamorrhage in placenta previa patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Single gestation
- Elective CS for placenta preiva (diagnosed by transvaginal ultrasound).
- Muliparity (para 2 or more).
Key exclusion criteria (14 listed)
- Morbidly adherent placenta: accrete, increta or percreta, diagnosed by abdominal and/or transvaginal ultrasound.
- More than 3 previous C.S.
- Severely haemodynamic instablility needing immediate hysterectomy.
- Patients with the cardiac, hepatic, renal or thromboembolic disease
- Patients with coagulopathy:
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 |
|---|---|---|
| B-Lynch Transverse Compression SutureAlso: B-Lynch Transverse Compression Suture using 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms sutureclosure of uterine and utero ovarian arteries bilaterally with one suture | Procedure or surgery | B-Lynch Transverse Compression Suture |
Primary outcome
Intraoperative blood loss
Time frame: 2 days following the procedure
Number of towels and blood in suction reservoir
Postoperative blood loss
Time frame: 2 days following the procedure
Postoperative blood loss in the drain bag
Number of received blood components
Time frame: 2 days following the procedure
Packed RBC's
Peripartum haemoglobin level drop
Time frame: 2 days following the procedure
Difference between pre and postoperative hemoglobin level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Yes. Statistical data discussion conclusion
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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.
Asmaa F Kassem, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Lynch Transverse Compression Suture in people with Blood Loss, Surgical, run by Alexandria 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed S Zeerban, Msc (+201003119968, Ahmedzeerban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: 2 days following the procedure). The study lists 4 primary outcomes in all. 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 11 Apr 2024.