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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preoperative; 1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation	Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml); IV 1gm
Experimental: uterine incision; 1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision	Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml); IV 1gm
No Intervention: placebo; 1ml of normal saline will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of blood loss during C-section.	ml	1 hour
Prevention of 1ry postpartum hemorrhage.	ml	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of hospital stay.	Number of days	48 hours
Decrease risk of maternal blood transfusion	Number of blood products units	48 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ayman Hany, MD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: tranexamic acid; high risk pregnancy; cesarean section.
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: FarahMSc2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No