Development of a Core Outcome Set for Trials on Induction of Labour
Research type
Research Study
Full title
Development of a Core Outcome Set for Trials on Induction of Labour - COSIOL
IRAS ID
203378
Contact name
Francois Sousa Dos Santos
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
This project relates to induction of labour. Labour is a natural process that usually starts on its own. Sometimes labour needs to be started artificially - this is called 'induced labour'.
Clinical trials involve research that is intended to add to medical knowledge and improve the way we treat patients. The results of a clinical trial are reported in terms of ‘outcomes’. A commonly used outcome in induction of labour is ‘mode of delivery’ (the way women gives birth after having induction of labour).
Although trials are designed to ensure that enough patients are examined to give them an accurate result, if we can examine more patients, we can be more confident in the result. When there are lots of trials which look at the same condition, researchers try to put all of the results together so that they undertake an analysis with lots of participants and therefore get a much stronger and reliable result. Unfortunately, trials don’t always report the same outcomes. If rules were developed that ensured that all trials which examine the same condition had to report the same outcomes it would be much easier to combine results and to develop guidelines based on the strongest available evidence.
Our aim is to prioritise outcomes for induction of labour. We will decide which outcomes should be tested based upon the opinions of obstetricians, midwives, baby doctors and women representatives. These outcomes will be known as a ‘core outcome set’. We will design a survey and ask participants to rate the importance of each outcome (on a scale from 1-9). The survey will be internet based and will have two rounds which will be sent out over a 2-month period. Once the core outcomes sets are finalised they will be publicised so that they can be brought into widespread use.
REC name
South East Scotland REC 01
REC reference
16/SS/0113
Date of REC Opinion
11 Jul 2016
REC opinion
Further Information Favourable Opinion