I invite you to take part in a research project concerning the use of oxytocin stimulation during labour:
We want to elucidate how the duration of stimulation with oxytocin affects the complication rate for mother and child. More than 1000 women from Denmark and The Netherlands will participate in the trial.
The purpose of the trial is to compare continued and discontinued oxytocin stimulation for labour induction when the active phase of labour is established.
Current clinical practice at the delivery ward is to continue oxytocin stimulation until the child and placenta has been delivered.
Due to a Danish pilotstudy we think that it is possible to pause oxytocin stimulation at an earlier point during the delivery, thereby reducing the risk of adverse events in mother and child, but at the expense of a slightly prolonged labour course.
Your participation contributes crucial knowledge to improve the treatment of pregnant women stimulated with oxytocin in the future.
Your treatment arm will be determined by randomisation. Neither you nor the staff at the delivery ward will know which infusion you will be assigned to. The oxytocin infusion will be replaced with either saline (placebo) or oxytocin infusion, when your cervix is dilated 6 cm.
I encourage you to read about your legal rights in the attached folder ”The rights of a trial subject in a biomedical research project”, before you decide whether you wish to participate or not.
If you wish to participate, you will receive a copy of the information sheet and a signed consent form to keep,.