B-lynch Transverse Compression Suture

NCT06359886 | Recruiting

• 1 other identifier: FMASU MD 292/2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

B-Lynch Transverse Compression Suture

EXPERIMENTAL

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

Interventions

B-Lynch Transverse Compression Suture PROCEDURE

closure of uterine and utero ovarian arteries bilaterally with one suture

Also known as: B-Lynch Transverse Compression Suture using 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms suture

B-Lynch Transverse Compression Suture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant females with Placenta Previa
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ain Shams University

Cairo, 21526, Egypt

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Central Study Contacts

Ahmed S Zeerban, Msc

CONTACT

+201003119968; Ahmedzeerban@gmail.com

Asmaa F Kassem, MD

CONTACT

+201067500789

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A Pilot Study

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2024
• Study Start: March 20, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Avilable from now onward
• Access Criteria: Transverse B-Lynch Placenta previa

Locations

EG (1)