Placenta Previa
Conditions
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.
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.
Sponsors
CMH Jhelum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Outcome results
None listed