Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
- Conditions
- Placenta Previa
- Interventions
- Registration Number
- NCT04518163
- Lead Sponsor
- Aswan University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 140
- women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group placebo to TA 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 control group 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 plus saline by intravenous infusion study group 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 plus 1gm tranexamic acid by intravenous infusion study group Tranexamic Acid 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
- Primary Outcome Measures
Name Time Method mean Blood loss after placental separation 30 minutes by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
- Secondary Outcome Measures
Name Time Method Number of Participants with postpartum hemorrhage 12 hours number pf participants with blood loss \> 1000ml
The number of participant needed of extra surgical maneuvers 30minutes Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation
Trial Locations
- Locations (1)
Aswan University Hospital
🇪🇬Aswan, Egypt