EFFICACY OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING CAESAREAN SECTION: A RANDOMIZED DOUBLE BLIND CONTROLLED MULTICENTRE STUDY
Not Applicable
- Conditions
- REDUCING BLEEDING AT LOWER SEGMENT CESAREAN SECTIONREDUCING BLEEDING AT LOWER SEGMENT CESAREAN SECTIO
- Registration Number
- PACTR202208847435444
- Lead Sponsor
- ODUOLAOWOO BAMUS BABTUNDE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 142
Inclusion Criteria
Age?=?18 years
Patients admitted for primary or secondary caesarean section (Elective or Emergency)
Gestational age of 36 to 42 weeks of gestation
Singleton pregnancy
Informed consent form signed
Exclusion Criteria
History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
Any known cardiovascular, renal, or liver disorders
Autoimmune disease
Sickle cell disease
Severe hemorrhagic disease
Planned general anesthesia
Placenta previa
Abruptio placentae
Eclampsia, HELLP syndrome
Multiple pregnancy
In utero fetal death
Administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery
Consent not obtained
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of TXA (1g) on post-operative blood loss.;To compare the percentage fall in post-operative haemoglobin between drug and placebo group.;To assess the need for additional uterotonic agents.<br>;To assess for presence of adverse effect of intravenous TXA ;There was a statistically significant difference in the calculated estimated blood loss among the intervention and the placebo arm of the study (P-value < 0.0001)
- Secondary Outcome Measures
Name Time Method The prevalence of PPH among the placebo group was four times that of the Tranexamic acid group. (P-value < 0.0001); There was no statistically significant difference in the use of additional uterotonic, blood transfusion and adverse effect profile between the two groups.