Placenta Previa
Conditions
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.
Interventions
DRUGTranexamic Acid
Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
DRUGplacebo to TA
Intravenous 110 ml saline by slow infusion before skin incision
DEVICEBakri 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
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind randomized controlled trial
Intervention model description
Double blind randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary Contacthany f Sallam, md
Backup Contactnahla w Shady, md
Outcome results
None listed