Clinical trial of the effect of topical tranexamic acid on the amount of episiotomy bleeding in primigravida women and comparison with the control group

In relation to postpartum bleeding, extensive studies have been conducted on the positive effect of tranexamic acid in reducing post-partum bleeding, its administration time, and effective dose, but its local effect on episiotomy bleeding in vaginal deliveries has not been investigated and the purpose of this study is to investigate this issue.

A clinical trial with a control group, with parallel groups, one-sided blind, randomized, 162 patients. The software was used for randomization.

place: Akbarabadi hospital maternity ward Immediately after the removal of the placenta, Trenexamic or normal saline solution will be poured locally on the episiotomy site. Take the solution freely without the interference of sterile gas and similar We pour it on the site and wait for a minute (the medicine is not injected on the site. The patient and the analyzer are blind.

Inclusion criteria: All vaginal births over 34 weeks in primiparous women who are candidates for episiotomy exclusion criteria: Lack of consent to participate in the study Patients with known coagulopathy History of previous perineal surgery Patients with uterine atony retained placenta Instrumental delivery Simultaneous rupture of the cervix Receiving venous tranexamic acid

In the intervention group, 1 gram of Trenoxamic acid with 20 cc of normal saline is poured at the episiotomy site. In the control group, 20 cc of normal saline is poured into the episiotomy site.

Hemoglobin and hematocrit changes, the need to receive blood, the duration of hospitalization, the rate of wound opening and the rate of wound infection, and the rate of thromboembolic events.

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.

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.