B-lynch Transverse Compression Suture

NCT ID: NCT06359886

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A Pilot Study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

B-Lynch Transverse Compression Suture

Intervention Type PROCEDURE

closure of uterine and utero ovarian arteries bilaterally with one suture

Interventions

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B-Lynch Transverse Compression Suture

closure of uterine and utero ovarian arteries bilaterally with one suture

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Zeerban

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed S Zeerban, Msc

Role: CONTACT

+201003119968

Asmaa F Kassem, MD

Role: CONTACT

+201067500789

Facility Contacts

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Ahmed S Zeerban, Msc

Role: primary

+201003119968

Other Identifiers

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FMASU MD 292/2022

Identifier Type: -

Identifier Source: org_study_id

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