Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section

NCT06060327 | Completed DMC

• 1 other identifier: MD-147-2021
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief Summary

The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini. Following a proper medical history taking, examination will be done, investigations including laboratory tests and obstetric ultrasound will be done. Then, the patients will be divided into 4 groups, receiving Oxytocin only (Group 1), Oxytocin + Tranexamic acid (Group 2), Oxytocin and Misoprostol (Group 3) or Oxytocin and Carbetocin (Group 4) followed by collection of necessary data.

Conditions

Postpartum Hemorrhage; Blood Loss, Postoperative; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Estimated Blood Loss

  To compare the estimated blood loss (EBL) during and after cesarean delivery among the four groups.

  1 year

Secondary Outcomes (3)

• Need for additional ecbolics

  1 year

• Excessive blood loss and need for blood transfusion

  1 year

• Side effects

  1 year

Study Arms (4)

Oxytocin Group

ACTIVE COMPARATOR

o In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta.

Drug: Tranexamic acid

Tranexamic acid

ACTIVE COMPARATOR

o In Tranexamic group (n=111), 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). Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.

Drug: Tranexamic acid

Misoprostol

ACTIVE COMPARATOR

o In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.

Drug: Tranexamic acid

Carbetocin

ACTIVE COMPARATOR

o In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta. Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

Giving oxytocin only, or oxytocin in addition to Tranexamic acid, Misoprostol or Carbetocin the mentioned doses and by the mention routes, then comparing the estimated blood loss in each group.

Also known as: Misoprostol, Carbetocin, Oxytocin

Carbetocin; Misoprostol; Oxytocin Group; Tranexamic acid

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Pregnant women candidate for LSCS. 3. Age: 20-40 years old. 4. Full term pregnancies (\> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
• \. Singleton pregnancies. 6. One or more of the following criteria to be considered as high-risk case for PPH (RCOG, 2016):
• Maternal Anemia (hemoglobin \< 10 g%).
• Known placenta previa.
• Proven or suspected case of placental abruption.
• Preeclampsia or gestational hypertension.
• Polyhydramnios (DVP \> 8cm).
• Macrosomia (\> 4 Kg)
• Previous history of uterine atony or postpartum hemorrhage).
• Prolonged labour (\>12 hours).
• \. CS under spinal anesthesia.

You may not qualify if:

• \. Fetal death (IUFD). 2. Fetal anomalies. 3. IUGR (Estimated fetal weight below the 5th centile) 4. Women presenting with an obstetric emergency necessitating immediate surgery (Cord prolapse, severe antepartum hemorrhage, severe fetal distress etc.) 5. More than 2 previous CS procedures. 6. Prolonged procedure (more than 2 hours from skin incision to skin closure). 7. History of prostaglandin, Tranexamic acid or carbetocin allergy. 8. Multifetal pregnancies. 9. Abnormally invasive placenta. 10. Known deep venous thrombosis

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

kasr elainy hospital (Faculty of Medicine - Cairo University)

Cairo, 115431, Egypt

Location

Faculty of medicine - Cairo university

Cairo, Egypt

Location

Related Publications (3)

• Chen CY, Su YN, Lin TH, Chang Y, Horng HC, Wang PH, Yeh CC, Chang WH, Huang HY. Carbetocin in prevention of postpartum hemorrhage: Experience in a tertiary medical center of Taiwan. Taiwan J Obstet Gynecol. 2016 Dec;55(6):804-809. doi: 10.1016/j.tjog.2016.07.009.

  PMID: 28040124 RESULT

• Prata N, Weidert K. Efficacy of misoprostol for the treatment of postpartum hemorrhage: current knowledge and implications for health care planning. Int J Womens Health. 2016 Jul 29;8:341-9. doi: 10.2147/IJWH.S89315. eCollection 2016.

  PMID: 27536161 RESULT

• Della Corte L, Saccone G, Locci M, Carbone L, Raffone A, Giampaolino P, Ciardulli A, Berghella V, Zullo F. Tranexamic acid for treatment of primary postpartum hemorrhage after vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(5):869-874. doi: 10.1080/14767058.2018.1500544. Epub 2018 Sep 10.

  PMID: 30122082 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage; Postoperative Hemorrhage

Interventions

Tranexamic Acid; Misoprostol; carbetocin; 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; Postoperative Complications

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amr K Rasheed, MsC

  Assistant Lecturer, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized controlled clinical trial including 4 groups comprising of 111 each. Group 1 will receive Oxytocin only, Group 2 will receive Oxytocin and Tranexamic acid, Group 3 will receive Oxytocin and Misoprostol and Group 4 will receive Oxytocin and Carbetocin.

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: October 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)