Opptimum Genetics
Research type
Research Study
Full title
Opptimum Genetics
IRAS ID
129928
Contact name
Jane E. Norman
Contact email
Research summary
A biobank of samples for studies of genetic associations of preterm labour would form a valuable resource for preterm birth research. Before a large-scale study is undertaken, strategies for sample collection, processing and analysis need evaluation. We propose a pilot study, which has four main aims.
1. to pilot postal sample collection.
2. to pilot methods of sample return and processing to confirm that samples provide sufficient high quality DNA yield.
3. to assess the agreement of self-reported pregnancy details with prospectively collected data.
4. to perform a “proof of concept” candidate gene analysis.
Participants will be women who are already part of a clinical trial of progesterone therapy to prevent preterm labour (the OPPTIMUM trial). We will contact potential participants by post, email or via the trial Facebook page , and invite them to contribute saliva samples from themselves +/- their baby and complete a short data questionnaire. If they agree we will send out study documentation, sample collection kits, and packaging to return the samples by post. Samples will be processed and stored in the Wellcome Trust Clinical Research Facility Genetics Core according to standard protocols adhering to clinical trial legislation. Pregnancy data will be entered onto a secure database. All personal identifying data will be removed, but will be linked to data stored on the OPPTIMUM trial database through a study number.
Questionnaire data obtained will be validated against prospectively collected trial data. A “proof of concept” candidate gene analysis will be performed with DNA genotyped for one or more single nucleotide polymorphisms in the progesterone receptor gene using Taqman primers. Associations of polymorphisms with spontaneous PTB less than 37 weeks' gestation and spontaneous PTB <34 weeks' will be examined.
Results will influence design of a large scale biobank of samples for the research into preterm labour and its complications.REC name
South East Scotland REC 01
REC reference
14/SS/0086
Date of REC Opinion
9 Jun 2014
REC opinion
Further Information Favourable Opinion