Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section

Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical; Blood Loss, Postoperative
• Intervention / Treatment: Drug: Oxytocin ,Tranexamic acid and Ethamsylate

Detailed Description

Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy).

Obstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries.

So many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity.

So these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Sayed Galal Hospital and Shoubra General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Pregnant females admitted for elective Cesarean Section.
2. Gestational age (38 to 41 weeks).
3. Age of the participants: 20 to 40 years.
4. Body Mass Index (18.5 - 29.9).
5. Singleton living fetus.
6. No medical disorders.
7. Informed written consent from the candidates.

Exclusion criteria:

1. - Medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid-stimulating hormone(TSH), all of them should be within normal limits).
2. -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
3. -Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
4. -Allergy to Tranexamic acid or any drug used.
5. -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
6. - Abnormal placentae such as placenta previa and placental abruption.
7. -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.
8. - Patients who refused spinal anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxytocin(only); oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section	Drug: Oxytocin ,Tranexamic acid and Ethamsylate; Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate; Other Names: Syntocinon , Kapron; Dicynon
Active Comparator: Tranexamic acid and Ethamsylate; Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section	Drug: Oxytocin ,Tranexamic acid and Ethamsylate; Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate; Other Names: Syntocinon , Kapron; Dicynon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.	First 2 hours after C-Section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sever PPH as bleeding is >1000 cc	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.	first 24 hours after C-Section

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Principal Investigator: Dr.,AbdelSattar M Farhan, Professor, Al-Azhar University, Faculty of medicine for boys; Principal Investigator: Dr.,ElSayed A. ElDesouky, Professor, Al-Azhar University, Faculty of medicine for boys

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: blood loss; Oxytocin; Cesarean Section; Tranexamic acid(Kapron); Etamsylate(Dicynon).
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Oxytocics; Oxytocin; Tranexamic Acid; Ethamsylate
• Other Study ID Numbers: DR,ABDELAZIM SOBHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Etamsylate .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No