Cereal bar or oral supplementation with tablets (BOOST)
Research type
Research Study
Full title
Cereal bar or oral supplementation with tablets to increases serum folate in young pregnant women.
IRAS ID
187152
Contact name
Annette Briley
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Pregnant teenage women will be invited to participate in the study up to 14 weeks' gestation. The aim is to investigate whether serum folate levels are improved at 20-22 weeks' gestation in teenage pregnant women randomised to take a pregnancy specific cereal bar daily compared with daily tablet supplementation (standard care). Young pregnant women will be told about the study at first antenatal appointment and recruited at first ultrasound scan appointment (11-14 weeks). Following informed consent, information will be collected from the women and an additional blood sample taken at time of routine venepuncture for screening tests. In addition participants will asked to complete a qualitative questionnaire regarding pregnancy health and experience. Women will be randomised to either 1 cereal bar per day or 1 tablet per day until their 20-22 week ultrasound scan appointment (maximum 11 weeks). The follow up visits will be undertaken at 16-17 weeks to replenish treatment supply and assess compliance, and when the women attend the anomaly scan at 20-22 weeks' gestation. At this visit (20-22 weeks) further data will be collected regarding pregnancy health, another blood sample will be taken (which is in addition to samples required for clinical care) and participants will be asked to complete a further questionnaire regarding their experience of taking whichever treatment they were randomised too. A subgroup will also be approached to take part in one to one telephone or face to face interviews with a qualitative researcher to further explore the women's experiences of supplementation in pregnancy.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1130
Date of REC Opinion
24 Aug 2016
REC opinion
Further Information Favourable Opinion