Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

NCT04656067 | Completed Phase 1

• 1 other identifier: DR,ABDELAZIM SOBHI
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical; Blood Loss, Postoperative

Keywords

blood loss; Cesarean Section; Oxytocin; Tranexamic acid(Kapron); Etamsylate(Dicynon).

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sever PPH as bleeding is >1000 cc

  first 24 hours after C-Section

Study Arms (2)

Oxytocin(only)

ACTIVE COMPARATOR

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

Tranexamic acid and Ethamsylate

ACTIVE COMPARATOR

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

Interventions

Oxytocin ,Tranexamic acid and Ethamsylate DRUG

Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate

Also known as: Syntocinon , Kapron, Dicynon

Oxytocin(only); Tranexamic acid and Ethamsylate

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \- 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).
• Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
• Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
• Allergy to Tranexamic acid or any drug used.
• Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
• \- Abnormal placentae such as placenta previa and placental abruption.
• Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.
• \- Patients who refused spinal anesthesia.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Sayed Galal Hospital and Shoubra General Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage; Hemorrhage

Interventions

Ethamsylate; Oxytocin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant specialist

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 7, 2020
• Study Start: April 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 10, 2020
• Last Updated: March 17, 2022

Record last verified: 2021-02

Locations

EG (1)