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

  • STATUS
    Recruiting
  • End date
    Jul 10, 2024
  • participants needed
    150
  • sponsor
    Assuta Ashdod Hospital
Updated on 7 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition Episiotomy Wound, Anemia, Early Postpartum Hemorrhage, Hemoglobin
Treatment Placebo, Tranexamic Acid
Clinical Study IdentifierNCT05448456
SponsorAssuta Ashdod Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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