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B-lynch Transverse Compression Suture

B-lynch Transverse Compression Suture in the Prophylaxis and Control of Postpartum Heamorrhage in Patients With Placenta Previa: A Pilot Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06359886
Enrollment
25
Registered
2024-04-11
Start date
2024-03-20
Completion date
2025-09-30
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical

Brief summary

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.

Interventions

PROCEDUREB-Lynch Transverse Compression Suture

closure of uterine and utero ovarian arteries bilaterally with one suture

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A Pilot Study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Single gestation 2. Elective CS for placenta preiva (diagnosed by transvaginal ultrasound). 3. Muliparity (para 2 or more).

Exclusion criteria

1. 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. 2. More than 3 previous C.S. 3. Severely haemodynamic instablility needing immediate hysterectomy. 4. Patients with the cardiac, hepatic, renal or thromboembolic disease 5. Patients with coagulopathy: * Receiving anticoagulant therapy. * With thrombocytopenia or thrombasthenia. * Known coagulation factor defect. 6. Distorted uterus as unicornuate, bicornuate, fibroid uterus and adenomyosis uteri.

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative blood loss2 days following the procedureNumber of towels and blood in suction reservoir
Postoperative blood loss2 days following the procedurePostoperative blood loss in the drain bag
Number of received blood components2 days following the procedurePacked RBC's
Peripartum haemoglobin level drop2 days following the procedureDifference between pre and postoperative hemoglobin level

Countries

Egypt

Contacts

Primary ContactAhmed S Zeerban, Msc
Ahmedzeerban@gmail.com+201003119968
Backup ContactAsmaa F Kassem, MD
+201067500789

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026