A Phase 2 interventional study of Misoprostol and Tranexamic acid in Post Partum Hemorrhage, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
The Efficacy and safety of Preoperative Intravenous Tranexamic acid versus Sublingual misoprostol in reducing blood loss during and after Elective Cesarean section among high risk pregnant cases.
The study will include (345) pregnant women attending for elective cesarean delivery in the Kasr Elaini hospital (faculty of medicine - Cairo university).
All the patients will be subjected to informed written consent, full medical history, clinical examination, obstetric ultrasonography, preoperative laboratory tests On the day of the scheduled surgery, participants will be randomly and equally assigned into three groups. Tranexamic group, Misoprostol group and oxytocin-only group (control group). Randomization will be performed using computer-generated random numbers.
In Tranexamic group (n=115), patients will be given 1 gm (10 ml) Tranexamic acid (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision).
In Misoprostol group (n=115), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be administered sublingually by the patients immediately before starting skin incision.
Following the delivery of the baby, patients in both Tranexamic and Misoprostol groups will additionally receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h).
In oxytocin-only group (n=115), patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby.
All cesarean sections will be done under spinal anesthesia by the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, immediate cord clamping (\< 30 seconds) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps).
The number and the difference of weight of operative towels (before and after CS) and amount of blood in suction unit will be recorded.
Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 12 hours after delivery.
Estimated Blood Loss (EBL) will be evaluated as follows:
The time interval between drug administration and fetal delivery will be recorded together with the neonatal outcome (APGAR at 1 and 5 minutes, NICU admission and neonatal death).
All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), the need for blood transfusion (within the first 24 hours), misoprostol-related side effects (in the first 6 hours) (i.e. shivering, pyrexia >38 C, headache, nausea, vomiting with or without the need for antiemetic drugs) and the occurrence of thromboembolic events (within one week of delivery).
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 345 is above 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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Exclusion Criteria:
patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision).
Drug: Tranexamic acid
patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision.
Drug: Misoprostol
patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby
Drug: Oxytocin
patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision (n=115)
Also known as: Cytotec
patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision) (n=115)
Also known as: Kapron
patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby (n=115)
Also known as: syntocinone
o compare the estimated blood loss (EBL) during cesarean delivery among the three groups
Estimated Blood Loss (EBL) will be evaluated as follows: A. The number of operative towels used. B. The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss). C. EBL calculation according to the following formula: EBL= EBV x \[(Preoperative hematocrit- Postoperative hematocrit)/ Postoperative hematocrit\]
Time frame: Intraoperative and within the first 24 hours postoperative.
The Use of additional ecbolics denoting uterine atony
5 IU intravenous bolus oxytocin and 1mL \[0.2 mg\] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively).
Time frame: within 24 hours postpartum
The occurrence of Excessive blood loss will be documented
Excessive blood loss (\> 1000 mL) and the need for blood transfusion will be documented
Time frame: within the first 24 hours postoperatively
Plan to share: No
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Cairo University