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OpenTrials
Completed

NCT Number: NCT05434533

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

IV 1gm

Primary outcomes

  1. Reduction of blood loss during C-section.

    Time frame: 1 hour

    ml

  2. Prevention of 1ry postpartum hemorrhage.

    Time frame: 24 hours

    ml

Secondary outcomes

  1. Reduction of hospital stay.

    Time frame: 48 hours

    Number of days

  2. Decrease risk of maternal blood transfusion

    Time frame: 48 hours

    Number of blood products units

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.