Balloon Tamponade Vs B-Lynch In Placenta Previa

Not Applicable

Completed

• Conditions: Placenta Previa
• Interventions: Procedure: Balloon Tamponade or B-Lynch

• Registration Number: NCT05133167
• Lead Sponsor: CMH Jhelum

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Last Update Submitted: 2021-11-15
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP A	Balloon Tamponade or B-Lynch	In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.
GROUP B	Balloon Tamponade or B-Lynch	In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

Primary Outcome Measures

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

Trial Locations

Locations (1)

CMH; 🇵🇰 Jhelum, Punjab, Pakistan