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

Not Applicable

Completed

• Conditions: Blood Loss, Surgical; Blood Loss, Postoperative
• Interventions: Drug: Oxytocin

• Registration Number: NCT05273632
• Lead Sponsor: Egymedicalpedia

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-10
• Study Start: 2022-03-20
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin	Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision
Tranexamic acid and Etamsylate	Oxytocin	Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery
Saline	Oxytocin	Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section

Primary Outcome Measures

Name	Time	Method
blood loss during and after cesarean delivery	First 2 hours after C-Section	Measuring of Hemoglobin level and Hematocrit level pre and post operatively.

Secondary Outcome Measures

Name	Time	Method
post operative bleeding	first 24 hours after C-Section	assessment of Hemoglobin level and Hematocrit level post operatively.

Trial Locations

Locations (1)

Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital; 🇪🇬 Cairo, Egypt