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The 35/39 Trial

Induction of labour versus expectant management for women over 35 years of age

Frequently Asked Questions

Who makes sure the trial is safe and well designed?

Before the trial was funded it was reviewed by an independent group of experts who determined that it was sensible and would result in a scientifically valid answer.

All research in the NHS is also looked at by an independent group of people called a Research Ethics Committee, to protect patient safety, rights, well-being and dignity. This study has been reviewed and given a favourable opinion by NHS by the Derby 1 Research Ethics Committee.

The study has also been reviewed and approved by the Research & Innovation department of Nottingham University Hospitals NHS Trust.

Why are these two treatments being compared?

Early labour induction is already sometimes offered in the NHS. But its introduction has been haphazard. Some consultants always offer it and some never do. When we asked a sample of recently delivered women over age 35 some felt it should be offered to everyone, and others were outraged that such a treatment was being offered at all without firm evidence of benefit. Only a properly conducted randomised trial will answer the question.

Who is funding the trial?

The trial is funded by the Department of Health through the Research for Patient Benefit (RfPB) programme which ‘supports high quality research for the benefit of users of the NHS in England’.

Who is organising the research?

By law, all clinical research conducted in the UK must have a sponsor. A sponsor is an organisation such as a hospital or research institute which is the ‘home base’ for the trial. The sponsor initiates and manages the clinical research. In the case of this trial, the Nottingham University Hospitals NHS Trust will act as a sponsor for the research.