Balloon Tamponade Vs B-Lynch In Placenta Previa

CMH Jhelum

Status: Completed

Conditions: Placenta Previa

Treatments: Procedure: Balloon Tamponade or B-Lynch

Study type: Interventional

Funder types: Other

Identifiers

NCT05133167

16112021

Details and patient eligibility

About

Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

Full description

After approval from hospital ethical committee, patients fulfilling the inclusion & exclusion criteria were recruited after taking informed written consent for surgery. Patients were allocated to group A and B using computer generated random sample allocation.

In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters.

In group B, B-lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

Enrollment: 60 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Singleton pregnancy
2. Late Third Trimester pregnancy (35+ weeks to 39 weeks)
3. Placenta Previa confirmed by ultrasonography
4. Elective Caesarean Section.

Exclusion criteria

1. Multiple gestation
2. Placenta accreta Spectrum (accrete/increta/percreta)
3. Bleeding diathesis
4. Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.
5. Serious medical or surgical diseases.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

GROUP A

Experimental group

Description:

In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.

Treatment:

Procedure: Balloon Tamponade or B-Lynch

GROUP B

Experimental group

Description:

In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

Treatment:

Procedure: Balloon Tamponade or B-Lynch