]>
IRCT20180409039247N4 IRCT 2023-02-23 Iran University of Medical Sciences The effect of topical tranexamic acid on the episiotomy bleeding, a clinical trial Clinical trial of the effect of topical tranexamic acid on the amount of episiotomy bleeding in primigravida women and comparison with the control group 2023-04-05 anticipated 162 Complete https://irct.ir/trial/68681 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: A computerized randomization list, generated by an independent statistician blinded to the trial and unrelated to the subjects involved, will use 1:1 allocation. All participants are blinded to the list. The randomization list will be administered using identical, sequentially numbered containers of study medication. These containers will be labeled identically by two investigators who will not be involved in recruiting study subjects. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6. The random assignment list is AAABBB-AABBAB-ABBBAA-AABABB-…., in this sequence A is transgenic and B is controlled, Blinding description: A single blind study in which the patient and the analyst are blinded. In the consent form, the patient is aware of the two study groups, but does not know whether he is in the intervention group or the control group. The researcher is not blind because he supervises the episiotomy process and uses the medicine. The nurse is not blind because the doctor prescribes the medicine. The information in the forms and the evaluation table are marked with codes that the analyst is blind to and does not know the type of division. N/A Episiotomy bleeding rate. Intervention 1: Tranexamic acid mixed with 20 cc of normal saline pored in episiotomy site. Intervention 2: Control group: 20 cc of normal saline pored in episiotomy site. 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 here is no further information"
public Maryam Fakehi
Bagheferdos station, Moulavi Street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 marjan_ghaemi@yahoo.com Iran University of Medical Sciences scientific Marjan Ghaemibidgoli
Emam khomeini hospital
Tehran Iran (Islamic Republic of) 14146 +98 21 8800 4858 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) vagina delivery beyond 34 weeks primiparity candidates for episiotomy 18 years 45 years Female Lack of consent to participate in the study known coagulopathy history of previous perineal surgery uterine atony retained placenta delivery with instruments Cervical rupture at the same time receiving spontaneous tranexamic acid O72 Postpartum hemorrhage Prevention Prevention Tranexamic acid mixed with 20 cc of normal saline pored in episiotomy site. Control group: 20 cc of normal saline pored in episiotomy site. The primary outcomes is changes in hemoglobin and hematocrit, the need for blood transfusion, the duration of hospitalization. Timepoint: Hemoglobin and hematocrit check before admission and 12 hours later and also to check complications 1 week after discharge. Method of measurement: Hemoglobin and hematocrit check with blood test (cbc) and check the need for transfusion, discharge time, possible wound opening and thromboembolic events based on history. Iran University of Medical Sciences Approved 2023-01-21 Iran university of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)