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

Egymedicalpedia

Status: Completed

Conditions: Blood Loss, Postoperative; Blood Loss, Surgical

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05273632

EL-SAYED EL-DESOUKY

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 3 patient groups, including a placebo group

Oxytocin

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Tranexamic acid and Etamsylate

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Oxytocin