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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448456
• Other study ID #: 0138-21-AA
• Status: Recruiting
• Phase: Phase 4
• Start date: July 25, 2022
• Est. completion date: July 10, 2024

Study information

• Verified date: August 2023
• Source: Assuta Ashdod Hospital
• Contact: Atara De Porto Amrany, MD
• Phone: +97556624055
• Email: atarad[@]assuta.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 10, 2024
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Episiotomy Wound
• Hemoglobin
• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic acid
1 gram of tranexamic acid in 100 ml of 0.9% normal saline
• Placebo
100 ml of 0.9% normal saline

Locations

Country	Name	City	State
Israel	Assuta ashdod	Ashdod	Shfela

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Ashdod Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta Hb levels	Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth)	24 hours from delivery
Secondary	PPH rate	early post partum hemorrhage	24 hours from delivery
Secondary	Uterotonics use	Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no	24 hours from delivery
Secondary	Blood transfusion	Use of Blood packed cells during hospitalization, dichotomies scale - yes or no	72 hours from delivery
Secondary	hospital admission	Number of hospital admission days	120 hours from delivery