Bleeding
Conditions
Brief summary
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.
Detailed description
To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.
Interventions
DRUGTranexamic Acid
Intravenous Injection
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* \- Women undergoing caesarean delivery for various elective indications. * Full term primiparas / multiparas. * Singleton pregnancy being delivered by LSCS.
Exclusion criteria
* \- Medical problems involving the heart, liver, kidney and brain . * Blood disorders. * Allergy to tranexamic acid. * History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology. * Multiple pregnancy, macrosomia. * Polyhydromnios . * Patients requiring blood transfusion due to anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of blood loss during cesarean section after placental delivery till end of the operation. | during and 2hours post cesarean section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours . | up to 24hours postoperative | composite |
| Adverse affect of tranexamic acid on mother and neonate . | first 24 hours | eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant . |
| 24 hours post operative haemoglobin and haematocrit . | after 24 hours. | composite |
Countries
Egypt
Contacts
Primary ContactMahmoud Shalby, MBBCH
Backup ContactAmr Abdelaziz, M.D
Outcome results
None listed