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

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    156
  • sponsor
    Cairo University
Updated on 4 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition High Risk Pregnant Women Undergoing Elective Cesarean Section
Treatment Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
Clinical Study IdentifierNCT05434533
SponsorCairo University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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