Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial

Conditions
-----------------
Placenta Previa

Intervention / Treatment
-----------------
* Procedure: Foley's Catheter
* Drug: TA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa Exclusion Criteria: Patients with a cardiac, hepatic, renal or thromboembolic disease patients with the high possibility of the morbid adherent placenta known coagulopathy or thromboembolic disease those presented with severe antepartum hemorrhage hypersensitivity or contraindications of use of tranexamic acid patient refuses to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foley's Catheter plus TA<br>patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision | Procedure: Foley's Catheter<br>* patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.<br>* Other names: Active Comparator;Drug: TA<br>* patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline<br>* Other names: active comparator;|
| Active Comparator: Foley's Catheter plus placebo to TA<br>patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision | Procedure: Foley's Catheter<br>* patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.<br>* Other names: Active Comparator;Drug: Placebo<br>* patients received 100 ml saline just before skin incision<br>* Other names: Placebo to TA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with postpartum hemorrhage | number of participant with blood loss > 1000ml | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | amount of blood loss during cesarean section | during the operation | 
| The number of participant needed for blood transfusion | Calculation of the number of participant needed for blood transfusion | 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 | 24 hours post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placenta previa, tranexamic acid, cesarean section, Foley's Catheter Balloon