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

NCT04117243 | Completed Phase 2 DMC

• 1 other identifier: 280391
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Hemorrhage

Keywords

tranexamic acid; misoprostol; high risk pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 \[(Preoperative hematocrit- Postoperative hematocrit)/ Postoperative hematocrit\]

  Intraoperative and within the first 24 hours postoperative.

Secondary Outcomes (2)

• The Use of additional ecbolics denoting uterine atony

  within 24 hours postpartum

• The occurrence of Excessive blood loss will be documented

  within the first 24 hours postoperatively

Study Arms (3)

Tranexamic group

ACTIVE COMPARATOR

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

Misoprostol group

ACTIVE COMPARATOR

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

Drug: Misoprostol

oxytocin only group

ACTIVE COMPARATOR

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

Interventions

Misoprostol DRUG

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

Misoprostol group

Tranexamic acid 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)

Also known as: Kapron

Tranexamic group

Oxytocin 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)

Also known as: syntocinone

oxytocin only group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37626292 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Tranexamic Acid; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Moutaz Elsherbini, MD

  assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in obstetrics and gynecology department

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: January 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)