Clinical trial NCT05434533: The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Official title: The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Risk Pregnant Women Undergoing Elective Cesarean Section
Keywords: high risk pregnancy
cesarean section.
tranexamic acid
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Reduction of blood loss during C-section.
timeFrame: 1 hour
measure: Prevention of 1ry postpartum hemorrhage.
timeFrame: 24 hours
Secondary outcomes:
measure: Reduction of hospital stay.
timeFrame: 48 hours
measure: Decrease risk of maternal blood transfusion
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Associate professor
name: Ayman Hany, MD
role: PRINCIPAL_INVESTIGATOR
References: