Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Placenta Previa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518163
• Other study ID #: aswu/279/7/19
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2020
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

• patients with the high possibility of morbid adherent placenta

• those presented with severe antepartum hemorrhage

• Patients with cardiac, hepatic, renal, or thromboembolic disease;

• hypersensitivity or contraindications of use of tranexamic acid

• patient refuses to consent

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Drug:
• Tranexamic Acid
Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
• 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

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean Blood loss after placental separation	by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set	30 minutes
Secondary	Number of Participants with postpartum hemorrhage	number pf participants with blood loss > 1000ml	12 hours
Secondary	The number of participant needed of extra surgical maneuvers	Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation	30minutes