Assuta ashdod
Ashdod, Shfela, 7712302, Israel
NCT Number: NCT05448456
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
Ashdod, Shfela, 7712302, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 gram of tranexamic acid in 100 ml of 0.9% normal saline
Other names: Hexakapron
100 ml of 0.9% normal saline
Other names: saline
Time frame: 24 hours from delivery
Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth)
Time frame: 24 hours from delivery
early post partum hemorrhage
Time frame: 24 hours from delivery
Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no
Time frame: 72 hours from delivery
Use of Blood packed cells during hospitalization, dichotomies scale - yes or no
Time frame: 120 hours from delivery
Number of hospital admission days
Assuta Ashdod Hospital
Other
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