TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin
Condition: Rectus Sheath Hematoma; Cesarean Section
MeSH terms: Hematoma
Study type: Interventional
Phase: Phase 4

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 with warfarin following cesarean section.
    

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 consent: patients representing the study population will be counselled about the
      intervention and informed written consent will be taken.

      Consenting patients will be subjected to the following:

      1. Detailed personal, obstetric and medical and surgical history. 2- Examination: General
      Examination.

        -  Vital signs: Blood pressure, pulse and temperature.

        -  Weight, height, BMI.

        -  Abdominal examination for assessment of fundal level. 3. Laboratory Investigations
           Preoperatively

        -  CBC, Coagulation Profile, Blood Chemistry. 5. Abdominal Ultrasound: in order to assess
           the following: a. Gestational age determination. c. Placental site. CS will be done by
           Senior Obstetricians, Using Standard CS technique, with visceral and parietal peritoneum
           re-approximation and insertion of a passive intraperitoneal drain. Fascial closure will
           be done using continuous slowly absorbable sutures. Meticulous hemostasis will be
           achieved using monopolar cauterization. An active drain (Hemovac®) will be applied in
           the space between anterior rectus sheath and the rectus abdominis muscle in all
           patients.

      Patients will be randomly assigned into three groups Randomization is done by computer
      generated random numbers in opaque envelops.

      Group 1:

      (21) patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)
      (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp,
      100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior
      rectus sheath and the rectus abdominis muscle, one sponge on each muscle.

      Group 2:

      (21) patients will have 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40
      cm2) Not impregnated with Tranexamic acid applied locally using the same method as the
      previous group.

      Group 3:

      (21) patients will have Neither Gelatin Sponge nor Tranexamic acid applied. Follow up
      patients for vital signs and manifestations of allergic reactions in the immediate post
      operative period.

      The intraperitoneal drain will be removed after 24 hours in all groups. While the (Hemovac®)
      drain will be removed after achieving target INR in all groups.

      All Patients will be receiving bridging anticoagulation using LMWH(Enoxaparin) alone for 3
      days in therapeutic doses (1mg/kg twice daily) to be initiated 12 hours after Surgery in most
      cases.Then Warfarin will be added on post operative day 3. LMWH will be withdrawn after
      achieving target INR.

      Then comparison between the three groups regarding

        -  Hemovac® Drain output in cc per day till achieving Target INR Levels for all patients.

        -  Ultrasound assessment of rectus sheath hematoma if present after achieving Target INR
           Levels for all patients.
    

Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention description(s): have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
Other intervention name(s): Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention