Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

Phase 1

Completed

• Conditions: Blood Loss, Surgical; Blood Loss, Postoperative
• Interventions: Drug: Oxytocin ,Tranexamic acid and Ethamsylate

• Registration Number: NCT04656067
• Lead Sponsor: Egymedicalpedia

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-10
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Status Verified: 2021-02
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid and Ethamsylate	Oxytocin ,Tranexamic acid and Ethamsylate	Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section
Oxytocin(only)	Oxytocin ,Tranexamic acid and Ethamsylate	oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section

Primary Outcome Measures

Name	Time	Method
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)	First 2 hours after C-Section	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.

Secondary Outcome Measures

Name	Time	Method
Sever PPH as bleeding is >1000 cc	first 24 hours after C-Section	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.

Trial Locations

Locations (1)

Sayed Galal Hospital and Shoubra General Hospital; 🇪🇬 Cairo, Egypt