Clinical trial NCT04656067: Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate
Official title: Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Blood Loss, Surgical
Blood Loss, Postoperative
Keywords: blood loss
Cesarean Section
Oxytocin
Tranexamic acid(Kapron)
Etamsylate(Dicynon).
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 230
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
timeFrame: First 2 hours after C-Section
Secondary outcomes:
measure: Sever PPH as bleeding is >1000 cc
timeFrame: first 24 hours after C-Section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sayed Galal Hospital and Shoubra General Hospital
Study officials:
affiliation: Al-Azhar University, Faculty of medicine for boys
name: Dr.,AbdelSattar M Farhan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University, Faculty of medicine for boys
name: Dr.,ElSayed A. ElDesouky, Professor
role: PRINCIPAL_INVESTIGATOR
References: