Tranexamic Acid vs Vasopressin in Placenta Previa Trial

Официальное название

Comparison of Efficacy of Tranexamic Acid Versus Vasopressin in Blood Loss Among Placenta Previa Patients Undergoing Cesarean Section

Обзор

Placenta previa is a major obstetric condition associated with increased risk of excessive blood loss during cesarean section, leading to maternal morbidity and mortality. Different pharmacological agents have been used to minimize intraoperative hemorrhage. Tranexamic acid is an antifibrinolytic agent, while vasopressin reduces blood loss by causing vasoconstriction and myometrial contraction at the injection site. Both drugs have been used separately in placenta previa cases, however direct comparison between tranexamic acid and vasopressin is limited. This randomized controlled trial will be conducted at the Department of Obstetrics \& Gynecology, AIMC/Jinnah Hospital Lahore. A total of 58 women (29 in each group), aged 18-45 years, with singleton pregnancy and diagnosed placenta previa undergoing elective cesarean section will be included. Participants will be randomly allocated into two groups. Group A will receive 1 gram tranexamic acid diluted in 20 ml of 5% dextrose intravenously 15 minutes before cesarean section. Group B will receive 4 units vasopressin diluted in 20 ml normal saline injected at placental implantation site after delivery of placenta. The primary outcome will be intraoperative blood loss measured by gauze saturation assessment and suction drain measurement. The study will help determine which drug is more effective in reducing blood loss in placenta previa patients undergoing cesarean section.

Подробное описание

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.

Вмешательства

• Препарат Group A: Tranexamic acid
  Injection Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section. (prophylactically)
• Препарат Group B: Vasopressin
  Injection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta.

Первичные конечные точки

• Intraoperative Blood Loss [Срок оценки: Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.]

Вторичные конечные точки (2)

• Need for Blood Transfusion [Срок оценки: Assessed within the immediate postoperative period (after surgery).]
• Drug Efficacy [Срок оценки: Assessed intraoperatively at completion of surgery.]

Критерии участия

Критерии включения

Women of reproductive age

Age 18-45 years

Diagnosed placenta previa in current pregnancy

Scheduled for elective cesarean section

Singleton pregnancy

Критерии исключения

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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Jinnah Hospital — Lahore

Публикации

• Kato S, Tanabe A, Kanki K, Suzuki Y, Sano T, Tanaka K, Fujita D, Terai Y, Kamegai H, Ohmichi M. Local injection of vasopressin reduces the blood loss during cesarean section in placenta previa. J Obstet Gynaecol Res. 2014 May;40(5):1249-56. doi: 10.1111/jog.12356. Epub 2014 Apr 21. PMID 24750470
• Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4. PMID 35287618

Идентификаторы

NCT: NCT07423156 · No 17 CMD/AIMC · CNIC No.: 32103-9070878-6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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