The PRECEPT Study
Research type
Research Study
Full title
A longitudinal cohort study into maternal cardiovascular and metabolic changes in fetal growth restriction with or without pre-eclampsia in pregnancy (PRECEPT Study)
IRAS ID
166240
Contact name
Christoph Lees
Contact email
Sponsor organisation
Imperial College Joint Research Compliance Office
Duration of Study in the UK
2 years, 10 months, 0 days
Research summary
During pregnancy, a woman's body adapts with changes in blood pressure, heart function and protein production. Abnormal cardiovascular and/or metabolic adaptation to pregnancy may be linked to the development of pregnancy
complications such as preeclampsia and/or growth restricted babies.Once diagnosed with preeclampsia and/or growth restriction in baby, there usually comes a point of clinical decompensation in mum and or baby, prompting urgent delivery of the baby.
For the PRECEPT study, we aim to recruit approximately 160 women, 100 of whom will have healthy ongoing pregnancies. The remaining 60 will be categorized based on preeclampsia (PE), fetal growth restriction (FGR) or both and further subdivided into 4 gestation bands .
In the PE and/or FGR groups, we will carry out cardiovascular and metabolic tests at diagnosis, throughout, and after pregnancy. In the healthy ongoing pregnancy group, we will see them to perform the same tests at around 28/32/36 weeks and after pregnancy.
The study is observational with no intervention. All cardiovascular tests are noninvasive,and women will be required to provide a urine and blood sample for metabolite analysis. Where possible, blood tests will be timed with clinically indicated blood sampling as part of their routine management.
Data from this study will establish a profile of values at different gestation and changes through pregnancy for cardiovascular and metabolite processes. If changes in cardiovascular function are seen prior to or in conjunction with clinical deterioration, it raises the prospect of prompt intervention and potential therapies.
The PRECEPT study will be conducted at Queen Charlotte's & Chelsea Hospital, Imperial Healthcare NHS Trust in close collaboration with the University of Cambridge (who has collaborated on the design of the protocol and loaned 'Innocor' - one of the machines used for cardiovascular testing)
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0341
Date of REC Opinion
9 Apr 2015
REC opinion
Further Information Favourable Opinion