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

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

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Procedure: B-Lynch Transverse Compression Suture

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed S Zeerban, Msc; Phone Number: +201003119968; Email: Ahmedzeerban@gmail.com
• Study Contact Backup: Name: Asmaa F Kassem, MD; Phone Number: +201067500789

Study Locations

• Egypt
  • Cairo, Egypt, 21526
    • Recruiting
    • ain shams University
    • Contact: Ahmed S Zeerban, Msc; Phone Number: +201003119968; Email: Ahmedzeerban@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B-Lynch Transverse Compression Suture; Transverse B-Lynch suture will be performed to these patients as a method of controlling postpartum heamorrhage in placenta previa patients	Procedure: B-Lynch Transverse Compression Suture; closure of uterine and utero ovarian arteries bilaterally with one suture; Other Names: B-Lynch Transverse Compression Suture using 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms suture

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 6, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: FMASU MD 292/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Statistical data discussion conclusion
• IPD Sharing Time Frame: Avilable from now onward
• IPD Sharing Access Criteria: Transverse B-Lynch Placenta previa
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No