The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

Study Design: A randomized case - controlled study.

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (placebo comparator).

Group C in which 109 women continued their labour course without any further augmentation.

The registry classes the interventions as drug.

More on the Plan

Informed consents were obtained from all patients after explanation of the aim of the study \& the potential risks.

Inclusion criteria included: maternal age between 20 \& 35 years old, gestational age 37 to 40 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan), vertex presentation of the fetus \& intact membranes.

Women who had chronic or pregnancy induced diseases or any contraindication to vaginal delivery (e.g. malpresentation, contracted pelvis \& placenta previa) were excluded.

Additional exclusion criteria included rhesus (Rh) negative or (O) blood group mothers, prolonged labour (\> 12h), fetal distress, instrumental delivery (forceps or vacuum extraction), abnormal fetal growth (IUGR or macrosomia), non-reassuring initial fetal CTG \& epidural analgesia.

Who Took Part

Enrollment: 327 planned participants were the target.

It was open to women only aged from 20 years up to 35 years.

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

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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.

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 2015-11 with completion listed for 2016-03.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: neonatal bilirubin level (time frame: 5 months).

It also tracked 1 secondary outcome, for example neonatal APGAR score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 327 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.