Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

What Was Tested

This registered phase 1, phase 2 trial tested Oxytocin for post-surgical inflammation and surgery recovery.

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

It had two arms (groups): Oxytocin(only) (active comparator) and Tranexamic acid and Ethamsylate (active comparator).

Oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section.

Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section.

The registry classes the interventions as drug.

More on the Plan

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).

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 Took Part

230 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: -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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-04-01 with completion listed for 2020-10-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 230 people with post-surgical inflammation and surgery recovery.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Post-surgical inflammation and surgery recovery research.