Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had three arms (groups): Tranexamic group (active comparator), Misoprostol group (active comparator) and oxytocin only group (active comparator).

The registry classes the interventions as drug.

More on the Plan

All the patients will be subjected to informed written consent, full medical history, clinical examination, obstetric ultrasonography, preoperative laboratory tests On the day of the scheduled surgery, participants will be randomly and equally assigned into three groups.

Tranexamic group, Misoprostol group and oxytocin-only group (control group).

Randomization will be performed using computer-generated random numbers.

The number and the difference of weight of operative towels (before and after CS) and amount of blood in suction unit will be recorded.

Who Took Part

Enrollment: 345 actual participants took part.

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: Pregnant women candidate for LSCS. Age: 20-40 years old. Full term pregnancies (\> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan). Singleton or twin pregnancies. Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, Thromboembolic disorders or coagulopathies).

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: fetal anomalies or iugr (estimated fetal weight below the 5th centile); women attending for emergency cs; more than 2 previous cs procedures.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-01-20 with completion listed for 2020-12-31.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: o compare the estimated blood loss (EBL) during cesarean delivery among the three groups (time frame: Intraoperative and within the first 24 hours postoperative).

It also tracked 2 secondary outcomes, for example The Use of additional ecbolics denoting uterine atony and The occurrence of Excessive blood loss will be documented.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 345 people.

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

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