Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

Egymedicalpedia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Blood Loss, Postoperative; Blood Loss, Surgical

Treatments: Drug: Oxytocin ,Tranexamic acid and Ethamsylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04656067

DR,ABDELAZIM SOBHI

Details and patient eligibility

About

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

Full description

Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy).

Obstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries.

So many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity.

So these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.

Enrollment: 230 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. • 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).
2. -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
3. -Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
4. -Allergy to Tranexamic acid or any drug used.
5. -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
6. • Abnormal placentae such as placenta previa and placental abruption.
7. -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.
8. • Patients who refused spinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 2 patient groups

Oxytocin(only)

Active Comparator group

Description:

oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section

Treatment:

Drug: Oxytocin ,Tranexamic acid and Ethamsylate

Tranexamic acid and Ethamsylate

Active Comparator group

Description:

Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section

Treatment:

Drug: Oxytocin ,Tranexamic acid and Ethamsylate