Balloon Tamponade Vs B-Lynch In Placenta Previa

CMH Jhelum60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Placenta Previa

Interventions

Balloon Tamponade or B-LynchPROCEDURE

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CMH

Jhelum, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Mean blood loss

Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

Time frame: 24 hours post procedure

Data from ClinicalTrials.gov

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