NCT04518163

Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade

Detailed description

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate. Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.

Conditions

• Placenta Previa

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
DRUG	placebo to TA	Intravenous 110 ml saline by slow infusion before skin incision
DEVICE	Bakri Balloon	Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-06-30
• Completion: 2022-07-31
• First posted: 2020-08-19
• Last updated: 2020-09-21

Locations

1 site across 1 country: Egypt