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IRCT20230307057644N2 IRCT 2024-07-30 Kerman University of Medical Sciences Investigating the effect of Tranexamic acid in bleeding after caesarean section. Investigating the effectiveness of the simultaneous use of Tranexamic acid and Oxytocin compared to the use of Oxytocin alone on the amount of bleeding after caesarean section . 2023-05-22 anticipated 140 Complete https://irct.ir/trial/69151 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We prepare some cards according to the sample size. On half of the cards we write intervention group and on the other half we write the control group. We put the cards in a basket. Then we randomly select them from the basket. After choosing each card, we number them in order and in the last stage according to the number of cards; we put them together. For example, card number 1 is the intervention group, card number 2 is the control group, card number 3 is the control group, etc. Then, without the patient or the doctor noticing, the researcher selects a card for each patient in the order we put and each patient is assigned to the intervention or control group, Blinding description: The study is double blind, the researcher selects the patient's card and if the card is from the intervention group, informs the nurse to inject The Oxytocin and Tranexamic acid and if the patient is from the control group, only to inject it with Oxytocin. The doctor and the patient do not know which patient is from the intervention group and which one is from the control group. 3 Postpartum hemorrhage. Intervention 1: Control group: In the third stage of labor, only 30 units of Oxytocin are injected intramuscular (IM) by the nurse to 82 patients included in the study. Intervention 2: Intervention group: In the third stage of labor; in addition to 30 units of Oxytocin (intramuscular), 1 g of Tranexamic acid is injected intravenously (IV) to 81 patients. Yes - There is a plan to make this available What will be shared: Total data When: Starting from six months after the publication of the article. To whom: Researchers, students and doctors Conditions: To conduct clinical trial Where to obtain: Public or scientific responsible person How to obtain: Send the proposal to the responsible persons email; mansori@kmu.ac.ir Comments:
public Ghazal Mansouri
University of Medical Sciences campus, at the beginning of Haft Bagh Alavi axis
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 mansori@kmu.ac.ir Kerman University of Medical Sciences scientific Ghazal Mansouri
University of Medical Sciences campus, at the beginning of Haft Bagh Alavi axis
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 mansori@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients who referred to Afzalipour Kerman Hospital for elective or emergency caesarean section in 2023. no limit no limit Female Patients with placenta Accreta and previa. Patients who have a history of uterine atony. Patients who have a history of uterine rupture. Patients who have a history of coagulation disorders. Patients with chorioamnionitis. Patients with hematologic disorders. Patients who have a history of myomectomy. O72 Postpartum hemorrhage Treatment - Drugs Treatment - Drugs Control group: In the third stage of labor, only 30 units of Oxytocin are injected intramuscular (IM) by the nurse to 82 patients included in the study. Intervention group: In the third stage of labor; in addition to 30 units of Oxytocin (intramuscular), 1 g of Tranexamic acid is injected intravenously (IV) to 81 patients. The amount of bleeding. Timepoint: Measuring the patient's hemoglobin before delivery and 6 hour after delivery. Method of measurement: Blood test for complete blood cells( CBC). Requirement to blood transfusions (Packed cell) and blood products (Platelets and Fresh Frozen Plasma). Timepoint: During delivery, 6 hours after delivery and one turn within the first 24 hours after delivery. Method of measurement: Due to the volume of bleeding during delivery and the rate of decrease in hemoglobin in the blood test. Uterine atony. Timepoint: It is checked every 15 minutes in the first hour after delivery, every 30 minutes in the second hour after delivery, and then during the first 2 to 24 hours after delivery. Method of measurement: Frequent examination of the uterine fundus. The need to use uterotonic drugs such as Methergin, Misoprostol, Factor 7, Prostaglandin. Timepoint: During delivery and the first 24 hours after delivery. Method of measurement: According to the amount of bleeding, which medicine was used based on the opinion of the obstetrician and gynecologist. The need to use a Bakri Balloon. Timepoint: During delivery and the first 24 hours after delivery. Method of measurement: According to the amount of bleeding, a Bakri Balloon is inserted based on the opinion of the obstetrician and gynecologist. The need for surgery to remove the uterus (hysterectomy). Timepoint: During delivery and the first 24 hours after delivery. Method of measurement: According to the amount of bleeding, hysterectomy is performed based on the opinion of the obstetrician and gynecologist. Kerman University of Medical Sciences Approved 2023-02-28 Ethics Committee of Kerman University of Medical Sciences Medical University Campus, Kerman University of Medical Science, Haft-Bagh Highway, Kerman Kerman Kerman Iran (Islamic Republic of)