Pregnancy Outcome Prediction Study 2 (POPS2)
Research type
Research Study
Full title
The evaluation and development of novel diagnostic methods to understand and prevent placentally-related complications of human pregnancy
IRAS ID
271826
Contact name
Gordon C. S. Smith
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
ISRCTN Number
ISRCTN12181427
Duration of Study in the UK
15 years, 11 months, 31 days
Research summary
Identifying women at high risk of pregnancy complications has proved problematic. Current methods are relatively crude and perform poorly. In the present study we aim to recruit, following informed written consent, approximately 4,500 women with a singleton pregnancy at the time of their dating ultrasound scan who have not had any previous births. We will obtain blood at around 12, 20, 28 and 36 weeks of gestation from the women and blood from the father of the baby (if present and consents) at one of these visits. We will also obtain samples at the time of birth, including placenta, membranes and blood from the umbilical cord. We will collect data from the participants through a questionnaire and by performing ultrasound scans at around 20, 28 and 36 weeks. We will link the research data to the woman's and baby's clinical records. The data and biological samples will provide a resource to develop and validate predictive tests for adverse pregnancy outcome. However, in addition to this, we will also perform a randomised controlled trial. Using data from the Pregnancy Outcome Prediction study, we have developed a test which identifies women at high risk of complications at around eight months of pregnancy (36 weeks). The blood sample, scan information and mother's characteristics will be used to identify women at high risk following the 36 week visit. These women will be randomised to have routine care (meaning that the high risk status will not be revealed) or to have the result revealed with the offer of intervention, principally, early delivery of the baby by induction of labour. The primary outcome of the trial is a composite of either preeclampsia (a pregnancy-specific complication resulting in high blood pressure and other problems) in the mother or growth restriction of the baby.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0331
Date of REC Opinion
23 Dec 2019
REC opinion
Further Information Favourable Opinion