B-lynch Transverse Compression Suture

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359886
• Other study ID #: FMASU MD 292/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Alexandria University
• Contact: Ahmed S Zeerban, Msc
• Phone: +201003119968
• Email: Ahmedzeerban[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Procedure:
• B-Lynch Transverse Compression Suture
closure of uterine and utero ovarian arteries bilaterally with one suture

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	Number of towels and blood in suction reservoir	2 days following the procedure
Primary	Postoperative blood loss	Postoperative blood loss in the drain bag	2 days following the procedure
Primary	Number of received blood components	Packed RBC's	2 days following the procedure
Primary	Peripartum haemoglobin level drop	Difference between pre and postoperative hemoglobin level	2 days following the procedure