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Completed

NCT Number: NCT04656067

Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sayed Galal Hospital and Shoubra General Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oxytocin ,Tranexamic acid and Ethamsylate

Drug

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

Other names: Syntocinon , Kapron, Dicynon

Primary outcomes

  1. Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)

    Time frame: 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 outcomes

  1. Sever PPH as bleeding is >1000 cc

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2020
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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