The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Reduction of blood loss during C-section.
Study Overview
Brief Summary
The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.
Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.
Detailed Description
All patients will undergo the following
I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.
III. Laboratory: Hemoglobin, Hematocrit before & after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.
VI. Calculation of blood loss:
The quantity of blood loss (ml) is calculated from 3 components :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •High risk women undergoing elective C-section
- •Hypertensive patients.
- •Obese patients.
- •Patients on LMWH.
- •Transverse lie
- •DM ( Type 1 & Gestational )
- •Cardiac ( Not on Anticoagulants )
- •Placenta Previa ( Not in PAS )
- •Previous uterine scar ( > previous 2 C- section )
Exclusion Criteria
- •Patients with bleeding tendency.
- •HELLP Syndrome.
- •Emergency C- section.
- •Mechanical prosthetic valve
- •Atrial Fibrillation.
- •Allery to tranexamic acid
- •Placenta Accreta , Increta , percreata.
Arms & Interventions
preoperative
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation
Intervention: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) (Drug)
uterine incision
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision
Intervention: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) (Drug)
Outcomes
Primary Outcomes
Reduction of blood loss during C-section.
Time Frame: 1 hour
ml
Prevention of 1ry postpartum hemorrhage.
Time Frame: 24 hours
ml
Secondary Outcomes
- Reduction of hospital stay.(48 hours)
- Decrease risk of maternal blood transfusion(48 hours)
Investigators
Ayman Hany, MD
Associate Professor
Cairo University