Risk of pregnancy
Research type
Research Study
Full title
Feasibility study to ascertain women of childbearing age at risk of pregnancy not using any contraception in THIN database
IRAS ID
249554
Contact name
Luis Alberto Garcia Rodriguez
Contact email
Sponsor organisation
BAYER PLC
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This is a feasibility study aiming to ascertain women of childbearing age at risk of pregnancy.\n\nThe study comprises 2 phases:\nPhase 1: develop and validate a computer-based algorithm (using medical codes such as Read codes and Gemstrip codes) to select women at risk of pregnancy not using any contraception from the THIN database.\nPhase 2: collecting information about contraceptive usage and fertility history from General Practitioners (GPs) and patients’ questionnaires.\n\nThe objective of this study is to evaluate whether the use of THIN database is a valid approach in selecting “women of childbearing age at risk of pregnancy not using any contraception” by comparing results obtained with the computer based algorithm (phase 1 of the study) with information collected from GPs and patients’ questionnaires (phase 2 of the study).\n\nPhase 1 and part of phase 2 (GP questionnaires) of the study have received approval from the Scientific Review Committee (SRC) [SRC ref: 17THIN071]. The SRC review of “research projects using THIN data not involving any patient contact” has been approved by the REC [ref: 07/H1102/103] and renewed in July 2018 [ref:18/LO/0441].\nThese parts of the study have now been completed.\n\nThis ethics application is related to the part of phase 2 which requires patient participation and seeks the committee’s favourable opinion before proceeding.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1898
Date of REC Opinion
21 Dec 2018
REC opinion
Unfavourable Opinion