COSTWIN - A core outcome set for clinical trials in twin pregnancy
Research type
Research Study
Full title
The development of a core outcome set for clinical trials in twin pregnancy
IRAS ID
263702
Contact name
Katie Morris
Contact email
Sponsor organisation
Birmingham Women's and Childrens Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Mothers and babies of twin pregnancies are at a higher risk of morbidity and mortality compared to singleton pregnancies which can also cause discordance between twins. This makes analysis of audits and effectiveness of trials particularly difficult as large outcome variations are reported. Consequently, there are significant barriers for international data meta-analysis which is further hampered by the use of different methods of measurement or definitions for an outcome. Therefore, in collaboration with The Core Outcome Measures in Effectiveness Trials initiative and the Core Outcomes in Women’s and Newborn Health initiative we aim to develop a core outcome set (COS) to be reported as a minimum in all twin pregnancy clinical trials.
The COS will be developed in three phases:-Phase one Identify all possible outcomes
A systematic review of all trials in twin pregnancy will be completed to ascertain outcomes previously used and qualitative interviews with people that have a lived experience of twin pregnancy will be performed to determine outcomes important to patients and families. The interviews will be performed in one of two ways and the participant can choose their preferred method - 1) attend a focus group at the Birmingham Women’s Hospital 2) complete a telephone interview.
Phase Two Decide which outcomes should form the COS
A modified Delphi survey with be conducted involving International expert stakeholders grouped into five panels of at least 15 participants in each (neonatologists, obstetricians, midwives, neonatal nurses, and patients). This will refine the combined list of outcomes reported in phase one to formulate the COS via consensus building between experts.
Phase Three Decide how each outcome is defined and measured
A consensus meeting, with all experts invited, will be held to finalise the COS and determine the appropriate methods for assessing each outcome.
This research is funded by Twins and Multiple Birth Association
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
19/YH/0191
Date of REC Opinion
18 Jun 2019
REC opinion
Favourable Opinion