NCT03741114

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Placenta Previa

Interventions

Type	Name	Description
PROCEDURE	Foley's Catheter	patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
DRUG	TA	patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
DRUG	Placebo	patients received 100 ml saline just before skin incision

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-11-30
• Completion: 2021-02-01
• First posted: 2018-11-14
• Last updated: 2019-01-09

Locations

1 site across 1 country: Egypt