Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries. The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.
Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
patients received 100 ml saline just before skin incision
Aswan University
Aswān, Egypt
RECRUITINGNumber of Participants with postpartum hemorrhage
number of participant with blood loss \> 1000ml
Time frame: 24 hours post operative
intraoperative blood loss
amount of blood loss during cesarean section
Time frame: during the operation
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Time frame: 24 hours postoperative
number of participant need of extra surgical maneuvers
number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy
Time frame: 24 hours post operative
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