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临床试验/NCT05448456
NCT05448456已完成4 期

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

Assuta Ashdod Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年7月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Delta Hb levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 18-45
  • 37-42 weeks gestation
  • Singleton pregnancy
  • Cephalic presentation

排除标准

  • 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

研究组 & 干预措施

Hexakakapron group

Active Comparator

women with an episiotomy after vaginal delivery

干预措施: Tranexamic acid (Drug)

control group

Placebo Comparator

women with an episiotomy after vaginal delivery

干预措施: Placebo (Drug)

结局指标

主要结局

Delta Hb levels

时间窗: 24 hours from delivery

Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth)

次要结局

  • PPH rate(24 hours from delivery)
  • Uterotonics use(24 hours from delivery)
  • Blood transfusion(72 hours from delivery)
  • hospital admission(120 hours from delivery)

研究者

发起方
Assuta Ashdod Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eran Brazilay, MD PhD

Head of the obstetric and gynecologic ultrasound unit

Assuta Ashdod Hospital

研究点 (1)

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