Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

NCT ID: NCT04518163

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

study group

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 plus 1gm tranexamic acid by intravenous infusion

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision

Bakri Balloon

Intervention Type: DEVICE

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

control group

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 plus saline by intravenous infusion

Group Type: ACTIVE_COMPARATOR

placebo to TA

Intervention Type: DRUG

Intravenous 110 ml saline by slow infusion before skin incision

Bakri Balloon

Intervention Type: DEVICE

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

Interventions

Tranexamic Acid

Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision

Intervention Type: DRUG

placebo to TA

Intravenous 110 ml saline by slow infusion before skin incision

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

TA; saline; BBT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

A Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

Aswan University Hospital

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f Sallam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

+20102435461 ext. 002

nahla w Shady, md

Role: CONTACT

hanygyne@yahoo.com

+201022336052 ext. 002

Facility Contacts

Hany F Sallam, MD

Role: primary

hany.farouk@aswu.edu.eg

0122336052 ext. 002

Nahla W Shady, MD

Role: backup

nahla.elsayed@aswu.edu.eg

01092440504 ext. 002

Other Identifiers

aswu/279/7/19

Identifier Type: -

Identifier Source: org_study_id