Status:

COMPLETED

TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin

Lead Sponsor:

Cairo University

Conditions:

Rectus Sheath Hematoma

Cesarean Section

Eligibility:

FEMALE

20-40 years

Phase:

PHASE4

Brief Summary

The aim of this randomized controlled study is to demonstrate the effect of Local application of TXA impregnated in a gelatin sponge in reducing Rectus sheath hematoma formation in patients treated wi...

Detailed Description

The study will include (63) pregnant women attending for cesarean delivery who will receive anticoagulation (warfarin) postnatally. Patients included in this study will be subjected to: \- Informed ...

Eligibility Criteria

Inclusion

  • o Pregnant women attending for elective CS.
  • Women on antenatal anticoagulation ( LMWH , UFH , Fondaparinux ) for conditions such as : Prosthetic Valve , DVT , Pulmonary embolism , Dural sinus thrombosis , AF.
  • Pregnant Women with indication for postnatal warfarin anticoagulation( Prosthetic Valve , DVT , Dural Sinus Thrombosis , AF , Pulmonary embolism )
  • Age between 20-40 years.
  • Pregnancies between 37 and 39 weeks
  • BMI between (18.5 - 30.0)

Exclusion

  • o Pregnancy with risk of obstetric hemorrhage such as abnormally invasive placenta, placenta previa, placental abruption.
  • Women with Renal and Hepatic failure
  • Women with bleeding diathesis for reasons other than warfarin anticoagulation therapy
  • Women with known allergy to Tranexamic acid
  • Anemia Hb below 8g/dl

Key Trial Info

Start Date :

July 3 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2023

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT05439694

Start Date

July 3 2022

End Date

February 1 2023

Last Update

February 21 2023

Active Locations (1)

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Cairo University

Cairo, Egypt

TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin | DecenTrialz