Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4).

It had two arms (groups): Group 1: Tranexamic acid group (experimental) and Group 2: oxytocin group (experimental).

The registry classes the interventions as drug.

More on the Plan

After The Ethical Research Committee approval on study protocol, fifty primigravida women at term pregnancy, undergoing elective cesarean delivery will be divided and allocated randomly into two groups after fulfillment eligibility criteria.

Fifty women will be included in this clinical study at admission to the labor ward.

Written informed permission will be acquired following advising about this study and potential implications.

A history in details and clinical examination for all patients to rule out general health problems.

Who Took Part

The registry lists 150 planned participants were the target.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women booked for a primary elective cesarean section, not in active labor. Aged between 20-40 years. BMI 18.5-29.9 kg/ m2 pre-pregnancy weight. Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes).

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: placenta previa; maternal hypertension and preeclampsia; diabetes mellitus.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2024-10-01 with completion listed for 2025-12-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Blood loss (time frame: 24 hours).

It also tracked 1 secondary outcome, for example Need of extra utero-tonic drugs.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 150 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.