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

NCT ID: NCT05434533

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-03
• Study Completion Date: 2023-02-10

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.

Conditions

High Risk Pregnant Women Undergoing Elective Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

preoperative

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

IV 1gm

uterine incision

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

IV 1gm

placebo

1ml of normal saline will be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

IV 1gm

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Hany, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman Hany, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FarahMSc2022

Identifier Type: -

Identifier Source: org_study_id