Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273632
• Other study ID #: EL-SAYED EL-DESOUKY
• Status: Completed
• Phase: N/A
• Start date: March 20, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

Description:

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant females admitted for Elective Cesarean Section.
• Gestational age of pregnancy (38 weeks To 40 weeks).
• the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
• Singleton living fetus.
• No medical disorders.
• Informed Oral Consent From The Patient.

Exclusion Criteria:

• Severe 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, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
• Acute liver or kidney diseases; blood disorders, such as anaemia.
• Allergy to Tranexamic acid.
• Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
• Ante partum Hemorrhage such placental abruption.

Related Conditions & MeSH terms

• Blood Loss, Postoperative
• Blood Loss, Surgical
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Oxytocin
trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Locations

Country	Name	City	State
Egypt	Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss during and after cesarean delivery	Measuring of Hemoglobin level and Hematocrit level pre and post operatively.	First 2 hours after C-Section
Secondary	post operative bleeding	assessment of Hemoglobin level and Hematocrit level post operatively.	first 24 hours after C-Section