Clinical trial NCT05448456: Use of Tranexamic Acid After Vaginal Delivery with Episiotomy a RCT Placebo Control Trail
Official title: Use of Tranexamic Acid After Vaginal Delivery with Episiotomy a RCT Placebo Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Episiotomy Wound
Anemia
Early Postpartum Hemorrhage
Hemoglobin
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. women aged 18-45
2. 37-42 weeks gestation
3. Singleton pregnancy
4. Cephalic presentation

Exclusion Criteria:

1. Any contra-indication for vaginal birth
2. PPH risk factors

   1. Dysfunctional labor
   2. Over distended uterus (macrosomia ,Polyhydramnios,multiple gestation)
   3. Grand multiparity
   4. Chorioamnionitis
   5. Precipitous labor
   6. Operative delivery
   7. Prolonged second stage
3. Previous pph
4. Preeclampsia
5. Placental abruption
6. Previous cesarean delivery
7. Thrombophilia or coagulopathy
8. Allergy to TA

Primary outcomes:
measure: Delta Hb levels
timeFrame: 24 hours from delivery
Secondary outcomes:
measure: PPH rate
timeFrame: 24 hours from delivery
measure: Uterotonics use
timeFrame: 24 hours from delivery
measure: Blood transfusion
timeFrame: 72 hours from delivery
measure: hospital admission
timeFrame: 120 hours from delivery
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta ashdod
state: Shfela
Study officials:
affiliation: Samson Assuta Ashdod University Hospital
name: Atara De Porto Amrany, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carbillon L, Uzan M, Uzan S. Pregnancy, vascular tone, and maternal hemodynamics: a crucial adaptation. Obstet Gynecol Surv. 2000 Sep;55(9):574-81. doi: 10.1097/00006254-200009000-00023.
citation: Kramer MS, Berg C, Abenhaim H, Dahhou M, Rouleau J, Mehrabadi A, Joseph KS. Incidence, risk factors, and temporal trends in severe postpartum hemorrhage. Am J Obstet Gynecol. 2013 Nov;209(5):449.e1-7. doi: 10.1016/j.ajog.2013.07.007. Epub 2013 Jul 16.
citation: Rossen J, Okland I, Nilsen OB, Eggebo TM. Is there an increase of postpartum hemorrhage, and is severe hemorrhage associated with more frequent use of obstetric interventions? Acta Obstet Gynecol Scand. 2010 Oct;89(10):1248-55. doi: 10.3109/00016349.2010.514324.
citation: Sosa CG, Althabe F, Belizan JM, Buekens P. Risk factors for postpartum hemorrhage in vaginal deliveries in a Latin-American population. Obstet Gynecol. 2009 Jun;113(6):1313-1319. doi: 10.1097/AOG.0b013e3181a66b05.