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

NCT ID: NCT05448456

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2024-09-01

Brief 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.

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.

Conditions

Episiotomy Wound; Anemia; Early Postpartum Hemorrhage; Hemoglobin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hexakakapron group

women with an episiotomy after vaginal delivery

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

1 gram of tranexamic acid in 100 ml of 0.9% normal saline

control group

women with an episiotomy after vaginal delivery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

100 ml of 0.9% normal saline

Interventions

Tranexamic acid

1 gram of tranexamic acid in 100 ml of 0.9% normal saline

Intervention Type: DRUG

Placebo

100 ml of 0.9% normal saline

Intervention Type: DRUG

Other Intervention Names

Hexakapron; saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assuta Ashdod Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eran Brazilay, MD PhD

Head of the obstetric and gynecologic ultrasound unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atara De Porto Amrany, MD

Role: PRINCIPAL_INVESTIGATOR

Samson Assuta Ashdod University Hospital

Locations

Assuta ashdod

Ashdod, Shfela, Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 10975484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23871950 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20809871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19461428 (View on PubMed)

Other Identifiers

0138-21-AA

Identifier Type: -

Identifier Source: org_study_id