Screening for preeclampsia in pregnancy, a prospective, observational, cohort study.

This is a prospective, observational, single-centre, cohort study, recruiting nulliparous women and their partners from Lyell McEwin Hospital (LMH), Adelaide, Australia. We will recruit a sample size of 1500 women (and their partners) who are experiencing a first-time pregnancy and receiving antenatal care at the LMH. Multiparous women will be excluded from this study. The standard antenatal visit (9-13 weeks’ gestation) will proceed as usual with midwives collecting routine information from the women, along with current Down syndrome screening (ultrasound between 11-13 weeks’ gestation) and Fetal Medicine Foundation (FMF) preeclampsia screening. At this visit, midwives will discuss the Northern Adelaide Preeclampsia (NAPS) screening test to all nulliparous women and eligible women and their partners who give signed informed consent will be recruited. Consent to participate includes i) obtaining delivery information (e.g. birthweight, length, head circumference, baby sex, and pregnancy complications) from maternal medical records; and ii) a cheek swab sample from the mother and the father of the baby. This is a simple test that involves twirling a swab/brush on the inner cheek for 15 seconds to obtain buccal (cheek) cells to obtain DNA and the time of the routine antenatal blood tests. The genetic information in the NAPS algorithms includes a range of maternal and paternal single nucleotide polymorphisms (SNPs). We are not testing for any genetic diseases or disabilities, so no other genetic information will be obtained. Approximately 1-2 weeks following this first antenatal visit (and before 16 weeks’ gestation), all participants will be seen to discuss aneuploidy risk and preeclampsia risk. This visit is part of standard antenatal care, but the discussion about preeclampsia risk is a service provided to participants. Any women found to be at risk of developing preeclampsia on a positive screen of the FMF test, will be prescribed with preventative low dose aspirin (before 16 weeks) as this is routine standard practice for women at high risk early preeclampsia. Diagnosis of preeclampsia is new onset hypertension developing in second half of pregnancy with proteinuria or other multisystem complications (e.g. HELLP) (ISSHP criteria). This study will be carried out for the duration of pregnancy and we will also collect information at delivery.