Tranexamic Acid vs Vasopressin in Placenta Previa Trial

This study is a randomized controlled trial designed to compare the efficacy of tranexamic acid versus vasopressin in reducing intraoperative blood loss among patients with placenta previa undergoing elective cesarean section. The study will be conducted in the Department of Obstetrics & Gynecology, Allama Iqbal Medical College (AIMC)/Jinnah Hospital, Lahore, over a maximum duration of 12 months after approval of synopsis.

A total sample size of 58 patients will be enrolled through non-probability purposive sampling. Women aged 18-45 years with singleton pregnancy and placenta previa scheduled for elective cesarean section will be included. Patients undergoing emergency cesarean section, having coagulation disorders, chronic liver/kidney disease, gestational diabetes, hypertensive disorders of pregnancy, history of postpartum hemorrhage, or using anticoagulant/antiplatelet drugs will be excluded.

After informed consent, baseline characteristics including age, gravida, para, abortion history, grade of placenta previa, and pre-operative hemoglobin will be recorded. Patients will be randomized into two groups using paper lottery method.

Group A will receive injection tranexamic acid 1 gram diluted in 20 ml of 5% dextrose administered intravenously 15 minutes before cesarean section. Group B will receive injection vasopressin 4 units diluted in 20 ml normal saline injected at placental implantation site after delivery of placenta. Both groups will receive standard uterotonic management with oxytocin 40 units in 500 ml of 5% glucose solution.

Blood loss will be assessed intraoperatively using visual gauze saturation method and suction drain volume. Post-operative hematocrit will be measured after achieving hemostasis and closure. Data will be analyzed using SPSS(statistical package of social sciences) version 26. Quantitative variables will be expressed as mean ± standard deviation and categorical variables as frequency and percentage. Independent sample t-test or Mann Whitney U test will be applied for comparison of quantitative variables, and Chi-square test for categorical variables. Stratification will be done for age and grade of placenta previa. A p-value ≤ 0.05 will be considered statistically significant.

The findings will help identify which intervention is more effective and safer for reducing intraoperative blood loss in placenta previa patients undergoing cesarean section.

Inclusion criteria

Women of reproductive age

Age 18-45 years

Diagnosed placenta previa in current pregnancy

Scheduled for elective cesarean section

Singleton pregnancy

Exclusion criteria

Emergency cesarean section

Platelet or coagulation disorder

Use of anti-platelet or anti-coagulant drugs

Previous history of postpartum hemorrhage

Chronic liver disease

Chronic kidney disease

Gestational diabetes

Pregnancy-related hypertensive disorders

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