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Completed

NCT Number: NCT05273632

Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

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Key information

Conditions

Blood Loss, Surgical Blood Loss, Postoperative Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital

Cairo, Egypt

About this study

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

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 of pregnancy (38 weeks To 40 weeks).
  • the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
  • Singleton living fetus.
  • No medical disorders.
  • Informed Oral Consent From The Patient.

Exclusion criteria

  • Severe 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, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
  • Acute liver or kidney diseases; blood disorders, such as anaemia.
  • Allergy to Tranexamic acid.
  • Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
  • Ante partum Hemorrhage such placental abruption.

Treatment and study plan

Oxytocin

Drug

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Other names: Tranexamic acid and Etamsylate

Primary outcomes

  1. blood loss during and after cesarean delivery

    Time frame: First 2 hours after C-Section

    Measuring of Hemoglobin level and Hematocrit level pre and post operatively.

Secondary outcomes

  1. post operative bleeding

    Time frame: first 24 hours after C-Section

    assessment of Hemoglobin level and Hematocrit level post operatively.

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Feb 8, 2023

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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