CONDISOX- continued versus discontinued oxytocin stimulation of induced labour in a double-blind randomised controlled trial

What Was Tested

This clinical study looks at Oxytocin.

The objective is to investigate how the caesarean section rate is affected when oxytocin stimulation is discontinued in the active phase of labour compared to labours where oxytocin is continued.

Why It Was Studied

NCT02553226 (registered September 17, 2015).

Who Took Part

According to the abstract, 1200 women were involved.

PubMed tags the participants as women only.

CONDISOX is a double-blind multicentre randomised controlled trial conducted at Danish and Dutch Departments of Obstetrics and Gynaecology.

The first participant was recruited on April 8 2016.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and multicenter.

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

Blinding on both sides kept the women and researchers unaware of who received Oxytocin.

Some women received a placebo instead of Oxytocin, giving a reference point.

Running at several centres spread the Oxytocin study over different clinics and patient groups.

The CONDISOX trial includes women at a gestational age of 37-42 complete weeks of pregnancy, who have uterine activity stimulated with oxytocin infusion for the induction of labour.

Women are randomised when the active phase of labour becomes established, to study medication containing either oxytocin (continuous group) or placebo (discontinued group) infusion.

Women are stratified by birth site, indication for oxytocin stimulation (induction of labour, prelabour rupture of membranes) and parity (nulliparous, parous +/- previous caesarean section).

The researchers will compare the primary outcome, caesarean section rate, in the two groups using a chi-square test with a p-value of 0.05.

Secondary outcomes include duration of the active phase of labour, incidence of uterine tachysystole, postpartum haemorrhage, admission to the neonatal intensive care unit, Apgar score, umbilical arterial blood pH, and birth experience.

What Was Measured

The subject headings attached to it are Apgar Score, Cesarean Section, Deprescriptions, Fetal Blood, Hydrogen-Ion Concentration, Intensive Care Units, Neonatal and Labor, Induced.

Author keywords: Caesarean section, Discontinuation, Induction of labour and Oxytocin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 1200 women.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 1 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2019 (BMC pregnancy and childbirth), a journal based in England.

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