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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Episiotomy Wound; Hemoglobin; Early Postpartum Hemorrhage
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Atara De Porto Amrany, MD; Phone Number: +97556624055; Email: atarad@assuta.co.il
• Study Contact Backup: Name: Eran Barzilay, Md PhD; Phone Number: +97233968985; Email: eranb@assuta.co.il

Study Locations

• Israel
  • Shfela
    • Ashdod, Shfela, Israel, 7712302
      • Recruiting
      • Assuta Ashdod
      • Contact: Atara De porto; Phone Number: 972 556624055; Email: ataradp@gmail.com
      • Contact: Elad Proiss; Phone Number: 972 45228700; Email: eladpreuss@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hexakakapron group; women with an episiotomy after vaginal delivery	Drug: Tranexamic acid; 1 gram of tranexamic acid in 100 ml of 0.9% normal saline; Other Names: Hexakapron
Placebo Comparator: control group; women with an episiotomy after vaginal delivery	Drug: Placebo; 100 ml of 0.9% normal saline; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta Hb levels	Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth)	24 hours from delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPH rate	early post partum hemorrhage	24 hours from delivery
Uterotonics use	Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no	24 hours from delivery
Blood transfusion	Use of Blood packed cells during hospitalization, dichotomies scale - yes or no	72 hours from delivery
hospital admission	Number of hospital admission days	120 hours from delivery

Collaborators and Investigators

• Sponsor: Assuta Ashdod Hospital
• Investigators: Principal Investigator: Atara De Porto Amrany, MD, Samson Assuta Ashdod University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): August 22, 2023
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 0138-21-AA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No