Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05434533
Enrollment
156
Registered
2022-06-28
Start date
2022-07-03
Completion date
2023-02-10
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Pregnant Women Undergoing Elective Cesarean Section

Keywords

high risk pregnancy, cesarean section., tranexamic acid

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.

Interventions

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

IV 1gm

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction of blood loss during C-section.1 hourml
Prevention of 1ry postpartum hemorrhage.24 hoursml

Secondary

MeasureTime frameDescription
Reduction of hospital stay.48 hoursNumber of days
Decrease risk of maternal blood transfusion48 hoursNumber of blood products units

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026