Clinical trial NCT06359886: B-lynch Transverse Compression Suture
Official title: B-lynch Transverse Compression Suture in the Prophylaxis and Control of Postpartum Heamorrhage in Patients With Placenta Previa: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Loss, Surgical
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Pilot Study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 2 days following the procedure
measure: Postoperative blood loss
timeFrame: 2 days following the procedure
measure: Number of received blood components
timeFrame: 2 days following the procedure
measure: Peripartum haemoglobin level drop
timeFrame: 2 days following the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: