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

Sponsor

Egymedicalpedia (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05273632

Collaborator

(none)

300

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

47.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Blood Loss, Surgical Blood Loss, Postoperative	Drug: Oxytocin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 20, 2022

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxytocin Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision	Drug: Oxytocin trial of reduction of losing blood intra operative or post operative during Cesarean Delivery Other Names: Tranexamic acid and Etamsylate
Active Comparator: Tranexamic acid and Etamsylate Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery	Drug: Oxytocin trial of reduction of losing blood intra operative or post operative during Cesarean Delivery Other Names: Tranexamic acid and Etamsylate
Placebo Comparator: Saline Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section	Drug: Oxytocin trial of reduction of losing blood intra operative or post operative during Cesarean Delivery Other Names: Tranexamic acid and Etamsylate

Arm

Intervention/Treatment

Active Comparator: Oxytocin

Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision

Drug: Oxytocin

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Other Names:

Tranexamic acid and Etamsylate

Active Comparator: Tranexamic acid and Etamsylate

Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery

Drug: Oxytocin

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Other Names:

Tranexamic acid and Etamsylate

Placebo Comparator: Saline

Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section

Drug: Oxytocin

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Other Names:

Tranexamic acid and Etamsylate

Outcome Measures

Primary Outcome Measures

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

post operative bleeding [first 24 hours after C-Section]
assessment of Hemoglobin level and Hematocrit level post operatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.