NCT05448456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

December 5, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

July 3, 2022

Last Update Submit

December 3, 2024

Conditions

Episiotomy WoundAnemiaEarly Postpartum HemorrhageHemoglobin

Outcome Measures

Primary Outcomes (1)

  • Delta Hb levels

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

    24 hours from delivery

Secondary Outcomes (4)

  • PPH rate

    24 hours from delivery

  • Uterotonics use

    24 hours from delivery

  • Blood transfusion

    72 hours from delivery

  • hospital admission

    120 hours from delivery

Study Arms (2)

Hexakakapron group

ACTIVE COMPARATOR

women with an episiotomy after vaginal delivery

Drug: Tranexamic acid

control group

PLACEBO COMPARATOR

women with an episiotomy after vaginal delivery

Drug: Placebo

Interventions

Tranexamic acidDRUG

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

Also known as: Hexakapron
Hexakakapron group
PlaceboDRUG

100 ml of 0.9% normal saline

Also known as: saline
control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta ashdod

Ashdod, Shfela, 7712302, Israel

Location

Related 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.

    PMID: 10975484BACKGROUND

  • 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.

    PMID: 23871950BACKGROUND

  • 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.

    PMID: 20809871BACKGROUND

  • 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.

    PMID: 19461428BACKGROUND

MeSH Terms

Conditions

AnemiaPostpartum Hemorrhage

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Atara De Porto Amrany, MD

    Samson Assuta Ashdod University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the obstetric and gynecologic ultrasound unit

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

July 25, 2022

Primary Completion

August 22, 2023

Study Completion

September 1, 2024

Last Updated

December 5, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)