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CompletedNCT05133167Updated Nov 24, 2021

Balloon Tamponade Vs B-Lynch In Placenta Previa

An interventional study of Balloon Tamponade or B-Lynch in Placenta Previa, sponsored by CMH Jhelum. Completed at 1 site in Pakistan. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-24.

Sponsored by CMH Jhelum · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Placenta Previa

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03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's enrollment of 60 is below the median of 109 across 45 interventional studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

CMH Jhelum is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    GROUP A

    In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.

    Procedure: Balloon Tamponade or B-Lynch

  • Experimental
    GROUP B

    In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

    Procedure: Balloon Tamponade or B-Lynch

Interventions

  • ProcedureBalloon 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • CMH
    Jhelum, Punjab 49600, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Will only share primary outcome result.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Oct 2021, 6 months.

Of 23 interventional studies with no phase under Placenta Previa, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2021
First posted
Nov 24, 2021
StartActual
Apr 1, 2021
Primary completionActual
Oct 1, 2021
CompletionActual
Oct 1, 2021
Last update
Nov 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05133167
Lead sponsor
CMH Jhelum
Responsible party
M. Awais Qarni (Anesthesiologist, CMH Jhelum) — Principal investigator
First posted
Nov 24, 2021
Start date
Apr 1, 2021
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021
Last update
Nov 24, 2021

Study contacts

Muhammad Awais Qarni
principal investigator · Anesthesiologist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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