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

What Was Tested

In this not phased trial, researchers set out to test Oxytocin for post-surgical inflammation and surgery recovery.

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

It had three arms (groups): Oxytocin (active comparator), Tranexamic acid and Etamsylate (active comparator) and Saline (placebo comparator).

Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision.

Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery.

The registry classes the interventions as drug.

Who Took Part

The registry lists 300 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 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.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the post-surgical inflammation and surgery recovery participants stayed in one arm throughout.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2022-03-20 with completion listed for 2022-09-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): blood loss during and after cesarean delivery (time frame: First 2 hours after C-Section).

It also tracked 1 secondary outcome, for example post operative bleeding.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 300 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.