Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656067
• Other study ID #: DR,ABDELAZIM SOBHI
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2020
• Est. completion date: November 10, 2020

Study information

• Verified date: February 2021
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 10, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Oxytocin ,Tranexamic acid and Ethamsylate
Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate

Locations

Country	Name	City	State
Egypt	Sayed Galal Hospital and Shoubra General Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative and Post operative bleeding(defined as blood loss =500 cc)	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.	First 2 hours after C-Section
Secondary	Sever PPH as bleeding is >1000 cc	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.	first 24 hours after C-Section