Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases

NCT ID: NCT04117243

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed Description

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 number of operative towels used.
• 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).
• the following formula: EBL= EBV x [(Preoperative hematocrit- Postoperative hematocrit)/ Postoperative hematocrit] Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).

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).

Conditions

Post Partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tranexamic group

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).

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

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)

Misoprostol group

patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision.

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision (n=115)

oxytocin only group

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

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

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)

Interventions

Misoprostol

patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision (n=115)

Intervention Type: DRUG

Tranexamic acid

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)

Intervention Type: DRUG

Oxytocin

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)

Intervention Type: DRUG

Other Intervention Names

Cytotec; Kapron; syntocinone

Eligibility Criteria

Inclusion Criteria

• Pregnant women candidate for LSCS.
• Age: 20-40 years old.
• Full term pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
• Singleton or twin pregnancies.
• Maternal Anemia (hemoglobin < 9.9 g%)
• Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, Thromboembolic disorders or coagulopathies).
• High risk case for obstetric hemorrhage (e.g. peripartum hemorrhage, accidental hemorrhage, placenta previa, previous history of uterine atony or postpartum hemorrhage).
• CS under spinal anesthesia.

Exclusion Criteria

• Fetal death (IUFD).
• Fetal anomalies or IUGR (estimated fetal weight below the 5th centile)
• Women attending for emergency CS.
• More than 2 previous CS procedures.
• Prolonged procedure (more than 2 hours from skin incision to skin closure).
• History of prostaglandin or Tranexamic acid allergy.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moutaz Sherbini

Assistant Professor in obstetrics and gynecology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moutaz Elsherbini, MD

Role: PRINCIPAL_INVESTIGATOR

assistant professor

Locations

Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

References

Dawoud M, Al-Husseiny M, Helal O, Elsherbini M, Abdel-Rasheed M, Sediek M. Intravenous tranexamic acid vs. sublingual misoprostol in high-risk women for postpartum haemorrhage following cesarean delivery; a randomised clinical trial. BMC Pregnancy Childbirth. 2023 Aug 25;23(1):611. doi: 10.1186/s12884-023-05935-5.

Reference Type: DERIVED

PMID: 37626292 (View on PubMed)

Other Identifiers

280391

Identifier Type: -

Identifier Source: org_study_id