Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

NCT06010368 | Not Yet Recruiting Phase 3

• 1 other identifier: AN2023-3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).

Conditions

Cesarean Section Complications; Tranexamic Acid; Oxytocin; Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Estimation of Intraoperative and postoperative blood loss.

  24 hours

Secondary Outcomes (1)

• Need of extra utero-tonic drugs

  2 hours

Study Arms (2)

Group 1: Tranexamic acid group

EXPERIMENTAL

In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.

Drug: Tranexamic acid injection

Group 2: oxytocin group

EXPERIMENTAL

to the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation

Drug: Oxytocin

Interventions

Tranexamic acid injection DRUG

In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.

Also known as: kapron

Group 1: Tranexamic acid group

Oxytocin DRUG

the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation

Also known as: syntocinone

Group 2: oxytocin group

Eligibility Criteria

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

You may not qualify if:

• Placenta previa.
• Maternal hypertension and Preeclampsia.
• Diabetes mellitus.
• Severe medical disorder (renal or hepatic).
• Multiple Fibroid uterus.
• Multiple pregnancies.
• Polyhydramnios.
• Previous uterine surgery as myomectomy.
• Contraindication to spinal anesthesia.
• Blood coagulopathy and bleeding disorder.
• Marked maternal anemia (Preoperative hemoglobin \<9 gm/dl).
• Contraindications to TXA or oxytocin therapy (e.g. allergy)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Suez Canal University

Ismailia, 8366004, Egypt

Location

Related Publications (5)

• El-Zanati FJICAfPM, Economic SRib, Knowledge SJU, B PoH. Egypt Health Issues Survey, Ministry of Health and Population, El-Zanaty and Associates and, ICF International. 2015:25-50.

  BACKGROUND

• Kebede BA, Abdo RA, Anshebo AA, Gebremariam BM. Prevalence and predictors of primary postpartum hemorrhage: An implication for designing effective intervention at selected hospitals, Southern Ethiopia. PLoS One. 2019 Oct 31;14(10):e0224579. doi: 10.1371/journal.pone.0224579. eCollection 2019.

  PMID: 31671143 BACKGROUND

• Brun R, Spoerri E, Schaffer L, Zimmermann R, Haslinger C. Induction of labor and postpartum blood loss. BMC Pregnancy Childbirth. 2019 Jul 25;19(1):265. doi: 10.1186/s12884-019-2410-8.

  PMID: 31345178 BACKGROUND

• Visconti F, Quaresima P, Rania E, Palumbo AR, Micieli M, Zullo F, Venturella R, Di Carlo C. Difficult caesarean section: A literature review. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:72-78. doi: 10.1016/j.ejogrb.2019.12.026. Epub 2020 Jan 7.

  PMID: 31962259 RESULT

• Boerma T, Ronsmans C, Melesse DY, Barros AJD, Barros FC, Juan L, Moller AB, Say L, Hosseinpoor AR, Yi M, de Lyra Rabello Neto D, Temmerman M. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2018 Oct 13;392(10155):1341-1348. doi: 10.1016/S0140-6736(18)31928-7.

  PMID: 30322584 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

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)

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

• Ahmed N Afifi, MD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

• Ahmed N Shaker, MD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed N Afifi, MD

CONTACT

00201098670624; dr_nagy.ahmed@yahoo.com

Ahmed N Afifi, MD

CONTACT

01098670624; ahmedafifi38527@postgrad.kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who will receive the actual drug and who will receive a placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of obstetrics and gynecology

Model Details: patients assigned to the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation. In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

EG (1)