Amniotomy and Oxytocin for Augmentation of Labour

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and morbidity.

Prolonged labour is most often defined as onset of regular , rhythmical painful contractions accompanied by cervical dilatation where labour is longer than 24 hours.prolonged active phase should not last longer than 12 hours without full assessment in a facility able to offer management and treatment of complications.Causes of prolonged labour usually due to poor or uncoordinated uterine action , fetal head malposition , and or abnormal pelvis either due to bone or soft tissue obstruction.

It had three arms (groups): Amniotomy first (active comparator), Oxytocin first (active comparator) and Amniotomy and oxytocin (active comparator).

Will be done with sterile gloves after insurance that is the baby's head fits in the pelvis ( 3\\5 or less of fetal head felt by first pelvic grip ) and by vaginal examination the head at station zero . The membranes are then punctured using an a hook during uterine contractions.

Amniotomy will be done (as explained above) and oxytocin (the same regimen mentioned above) at the same time.

The registry classes the interventions as drug and procedure.

Who Took Part

150 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Women in spontaneous labor. Women with intact membranes at the time of randomization. Cervical dilatation 3 cm or more. Gestational age 37 weeks or more proved by reliable dates or by early ultrasound scan in the first trimester. Slow progress in the active phase of labor ( cervical dilatation less than 1 cm \\hour).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: women with a previous uterine scar; severe preeclamptic toxemia; women with any congenital malformations.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2014-04-01 with completion listed for 2014-09-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of cervical dilatation (time frame: every hour up to full cervical dilatation).

It also tracked 2 secondary outcomes, for example Augmentation delivery time and Apgar score at 10 minutes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 150 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.