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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05434533
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase Phase 4
Start date July 3, 2022
Completion date February 10, 2023