B-lynch Transverse Compression Suture

Alexandria University

Status: Enrolling

Conditions: Blood Loss, Surgical

Treatments: Procedure: B-Lynch Transverse Compression Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT06359886

FMASU MD 292/2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

B-Lynch Transverse Compression Suture

Experimental group

Description:

Transverse B-Lynch suture will be performed to these patients as a method of controlling postpartum heamorrhage in placenta previa patients

Treatment:

Procedure: B-Lynch Transverse Compression Suture