A Phase 4 interventional study of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) in High Risk Pregnant Women Undergoing Elective Cesarean Section, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Cairo University · Phase 4, Interventional, and Prevention
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.
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 :
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 156 is close to the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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High risk women undergoing elective C-section
Exclusion Criteria:
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation
Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision
Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
1ml of normal saline will be given
IV 1gm
Reduction of blood loss during C-section.
ml
Time frame: 1 hour
Prevention of 1ry postpartum hemorrhage.
ml
Time frame: 24 hours
Reduction of hospital stay.
Number of days
Time frame: 48 hours
Decrease risk of maternal blood transfusion
Number of blood products units
Time frame: 48 hours
Plan to share: No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Cairo University