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Balloon Tamponade Vs B-Lynch In Placenta Previa

Primary Purpose

Placenta Previa

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Balloon Tamponade or B-Lynch
Sponsored by
CMH Jhelum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • CMH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GROUP A

GROUP B

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2021
Last Updated
November 15, 2021
Sponsor
CMH Jhelum
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1. Study Identification

Unique Protocol Identification Number
NCT05133167
Brief Title
Balloon Tamponade Vs B-Lynch In Placenta Previa
Official Title
Comparison of Efficacy of Surgical Interventions (Balloon Tamponade Versus B-lynch Suture) to Prevent Postpartum Hemorrhage in Patients With Placenta Previa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CMH Jhelum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Experimental
Arm Description
In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.
Arm Title
GROUP B
Arm Type
Experimental
Arm Description
In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.
Intervention Type
Procedure
Intervention Name(s)
Balloon Tamponade or B-Lynch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean blood loss
Description
Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.
Time Frame
24 hours post procedure

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Singleton pregnancy Late Third Trimester pregnancy (35+ weeks to 39 weeks) Placenta Previa confirmed by ultrasonography Elective Caesarean Section. Exclusion Criteria: Multiple gestation Placenta accreta Spectrum (accrete/increta/percreta) Bleeding diathesis Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc. Serious medical or surgical diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Awais Qarni
Organizational Affiliation
Anesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMH
City
Jhelum
State/Province
Punjab
ZIP/Postal Code
49600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will only share primary outcome result.

Learn more about this trial

Balloon Tamponade Vs B-Lynch In Placenta Previa

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