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Completed

NCT Number: NCT05133167

Balloon Tamponade Vs B-Lynch In Placenta Previa

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.

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Key information

Conditions

Placenta Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CMH

Jhelum, Punjab Province, 49600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balloon Tamponade or B-Lynch

Procedure

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 outcomes

  1. Mean blood loss

    Time frame: 24 hours post procedure

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

Sponsors and collaborators

Lead sponsor

CMH Jhelum

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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