Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the effect of TA treatment on decline in Hb levels following vaginal delivery with an episiotomy, compared to a control group not receiving TA.

Detailed Description
-----------------
Vaginal delivery is often characterized by excessive blood loss. Normal range of blood loss in uncomplicated vaginal delivery is up to 500 ml. Despite this, most women can adapt due to hemodynamic changes that occur during pregnancy Several factors during labor can promote major blood loss that may be defined as post-partum hemorrhage (PPH) Early PPH (E-PPH) is defined by the World Health Organization as blood loss from the birth canal in excess of 500 ml during the first 24 hours after delivery E-PPH occurs in up to 6% of births and it is one of the main causes of maternal morbidity and mortality accounting for about 25% of maternal deaths worldwide Among morbidities, E-PPH can lead to post-partum anemia (PPA). PPA incidence is estimated between 50%-80% of women PPA is defined as level of hemoglobin (Hb) of 11 gr/dl one week after delivery Anemia is associated with fatigue, post-partum depression and is a significant health problem in women during the reproductive age . One of the major causes of E-PPH is perineal trauma. Perineal trauma is present in up to 85% of births either due to an episiotomy or spontaneous tear or a combination of them both During the the second stage of labor, the midwife or the obstetrician may need to make a surgical incision (episiotomy) to increase the diameter of the vaginal outlet and facilitate the baby's birth This procedure is done with scissors or scalpel and requires repair by suturing (14). In the United States, episiotomy rate was 11.6% in 2012 In a study published by Alvarez et al in 2017, the average reduction in Hb was 1.46 ± 1.09 g/dl following vaginal delivery with a second degree tear but without an episiotomy and 2.07 ± 1.24 following vaginal delivery with an episiotomy and no perineal tear. The greatest reduction in Hb occurred among women with episiotomy and a third or fourth degree tear with a decrease of 3.1 ± 1.32 g/dl. Different strategies have been described for preventing and treatment PPH, including active management of the third stage of labor, among them uterine massage and controlled cord traction in addition to oxytocin and the use of Tranexamic acid (TA) as PPH treatment Tranexamic acid (TA) is a lysine analog, which acts as an antifibrinolytic via competitive inhibition to the binding of plasmin and plasminogen to fibrin. TA reaches peak plasma concentration immediately after intravenous administration A meta-analysis evaluated the use of tranexamic acid after vaginal delivery for prevention of primary PPH. When used as prophylaxis within 10 min after vaginal delivery usually at the dose of 1 g IV, in addition to standard prophylaxis with oxytocin, tranexamic acid reduced the risk of primary PPH and the mean post-partum blood loss However there are no studies that evaluated the impact of TA on blood loss after vaginal deliveries with an episiotomy.

Official Title
-----------------
Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail

Conditions
-----------------
Episiotomy Wound, Anemia, Early Postpartum Hemorrhage, Hemoglobin

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 18-45 37-42 weeks gestation Singleton pregnancy Cephalic presentation Exclusion Criteria: Any contra-indication for vaginal birth PPH risk factors Dysfunctional labor Over distended uterus (macrosomia ,Polyhydramnios,multiple gestation) Grand multiparity Chorioamnionitis Precipitous labor Operative delivery Prolonged second stage Previous pph Preeclampsia Placental abruption Previous cesarean delivery Thrombophilia or coagulopathy Allergy to TA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hexakakapron group<br>women with an episiotomy after vaginal delivery | Drug: Tranexamic acid<br>* 1 gram of tranexamic acid in 100 ml of 0.9% normal saline<br>* Other names: Hexakapron;|
| Placebo Comparator: control group<br>women with an episiotomy after vaginal delivery | Drug: Placebo<br>* 100 ml of 0.9% normal saline<br>* Other names: saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta Hb levels | Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth) | 24 hours from delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPH rate | early post partum hemorrhage | 24 hours from delivery | 
| Uterotonics use | Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no | 24 hours from delivery | 
| Blood transfusion | Use of Blood packed cells during hospitalization, dichotomies scale - yes or no | 72 hours from delivery | 
| hospital admission | Number of hospital admission days | 120 hours from delivery |