The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: High Risk Pregnant Women Undergoing Elective Cesarean Section

Treatments: Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT05434533

FarahMSc2022

Details and patient eligibility

About

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.

Full 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 :

• (weight of used towels during surgery - weight of used towels prior to surgery),plus
• (volume of blood sucked in suction container after placental delivery) ,plus
• (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)
• Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al).

VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .

All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.

Enrollment: 156 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

preoperative

Experimental group

Description:

1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation

Treatment:

Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)

uterine incision

Experimental group

Description:

1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision

Treatment:

Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)

placebo

No Intervention group

Description:

1ml of normal saline will be given