Balloon Tamponade Vs B-Lynch In Placenta Previa

Placenta Previa Clinical Trial

Official title:

Comparison of Efficacy of Surgical Interventions (Balloon Tamponade Versus B-lynch Suture) to Prevent Postpartum Hemorrhage in Patients With Placenta Previa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133167
• Other study ID #: 16112021
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2021
• Source: CMH Jhelum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Procedure:
• Balloon Tamponade or B-Lynch
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.

Locations

Country	Name	City	State
Pakistan	CMH	Jhelum	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
CMH Jhelum

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood loss	Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.	24 hours post procedure