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

Phase 4

Completed

• Conditions: High Risk Pregnant Women Undergoing Elective Cesarean Section
• Interventions: Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)

• Registration Number: NCT05434533
• Lead Sponsor: Cairo University

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 :

* (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.

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-26
• Study First Posted: 2022-06-28
• Study Start: 2022-07-03
• Primary Completion: 2023-01-01
• Status Verified: 2023-02
• Study Completion: 2023-02-10
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative	Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)	1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation
uterine incision	Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)	1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision

Primary Outcome Measures

Name	Time	Method
Reduction of blood loss during C-section.	1 hour	ml
Prevention of 1ry postpartum hemorrhage.	24 hours	ml

Secondary Outcome Measures

Name	Time	Method
Reduction of hospital stay.	48 hours	Number of days
Decrease risk of maternal blood transfusion	48 hours	Number of blood products units

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt