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IRCT20101130005280N44 IRCT 2021-12-14 Mashhad University of Medical Sciences Comparative study of tranexamic acid Comparative study of tranexamic acid on the prevention and decrease of Postpartum Hemorrhage in high-risk women 2021-11-21 anticipated 214 Complete https://irct.ir/trial/59708 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method is simple among pregnant women 37-40 weeks with age between 20 to 40 years, patient allocation sequence will be done using blocked methods. Using the site sealedenvelope.com, four blocks of random sequence will be generated. Then, the sequence of assignment of the subjects in the two groups was included in the envelope, and based on the number of envelopes, the subjects were assigned to the two groups, Blinding description: The subjects and those evaluating the outcome will be unaware of the intervention and control groups. Pregnant women will be randomly treated with an intervention and control regimen and do not know which group they belong to. Evaluate a group of researchers who do not know the details of the research. 3 Occurrence of postpartum hemorrhage. Intervention 1: Intervention group: In the intervention group, one gram of tranexamic acid will be injected immediately after delivery.Bleeding rate in the first 2 hours, 12 and 24 hours after delivery (measurement of bleeding volume by weighing gases and blood shanks, where each whole blood gase is equal to 10 cc of blood and long gas is equal to 50 cc of blood and sub-patient shans Blood loss (based on hemoglobin and hematocrit measured 24 hours after delivery) will be assessed in two groups. Intervention 2: In the control group, only the volume of tranexamic acid vial of normal saline will be injected.Bleeding rate in the first 2 hours, 12 and 24 hours after delivery (measurement of bleeding volume by weighing gases and blood shanks, where each whole blood gase is equal to 10 cc of blood and long gas is equal to 50 cc of blood and sub-patient shans Blood loss (based on hemoglobin and hematocrit measured 24 hours after delivery) will be assessed in two groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After finishing work, consult with colleagues and it will be published if all members
public Hoda Hosseini
Ayatollah Behjat St. Umm Al-Banin Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 3492 Hoseinih961@mums.ac.ir Mashhad University of Medical Sciences scientific Farideh Akhlaghi
Ayatollah Behjat St. Umm Al-Banin Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 3492 Hoseinih961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) For pregnant mothers between 37-40 weeks, age between 20 to 40 years Satisfaction to participate in the study History of postpartum hemorrhage in previous pregnancy Macrosomic more than 4 kg Polyhydramnios History of thromboembolic events Lower limb varicose veins aggregate more than 24 hours Very fast labor and high parity Chorioamnionitis and placental abruption 20 years 40 years Female Multiple pregnancies Placental abnormalities Preeclampsia Liver disorders Kidney, brain and ... Treatment - Other Treatment - Other Intervention group: In the intervention group, one gram of tranexamic acid will be injected immediately after delivery.Bleeding rate in the first 2 hours, 12 and 24 hours after delivery (measurement of bleeding volume by weighing gases and blood shanks, where each whole blood gase is equal to 10 cc of blood and long gas is equal to 50 cc of blood and sub-patient shans Blood loss (based on hemoglobin and hematocrit measured 24 hours after delivery) will be assessed in two groups. In the control group, only the volume of tranexamic acid vial of normal saline will be injected.Bleeding rate in the first 2 hours, 12 and 24 hours after delivery (measurement of bleeding volume by weighing gases and blood shanks, where each whole blood gase is equal to 10 cc of blood and long gas is equal to 50 cc of blood and sub-patient shans Blood loss (based on hemoglobin and hematocrit measured 24 hours after delivery) will be assessed in two groups. The amount of bleeding. Timepoint: In the first 2 hours (each quarter) and 12 and 24 hours after delivery. Method of measurement: Measure the amount of blood lost. The amount of hemoglobin drop in both groups. Timepoint: In the first 2 hours (each quarter) and 12 and 24 hours after delivery. Method of measurement: The amount of hemoglobin is checked before and after delivery. Mashhad University of Medical Sciences Approved 2018-12-25 Ethics committee of Mashhad University of Medical Science Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street MASHHAD Razavi Khorasan Iran (Islamic Republic of)