The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose. The study aims at determining the performance parameters (specificity, sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the test and its applicability. To do this, the investigators will use the serum samples of the patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international study conducted between years 2004-2008.

The test has been developed in a case-control study. In this clinical trial the investigators will test it in a large cohort that is likely to resemble a real population. The purpose of validation is to see if the test is able to recognize the few malformed fetuses in the entire population and especially its specificity in real conditions. In addition, the investigators will check whether particular maternal conditions (such as preeclampsia, gestational diabetes, etc.) or fetal conditions (Small for gestational age, Large for gestational age, etc.) affect the test results.

Inclusion criteria were the ones designed by SCOPE Study:

- Nulliparous women, with a singleton pregnancy, between 14wks, 0 days and 16wks, 6 days gestation who give informed consent to participate in SCOPE.

Exclusion criteria were the ones designed by SCOPE Study:

• Unsure of last menstrual period (LMP)
• Unwilling to have ultrasound scan at ≤20 weeks
• ≥3 miscarriages
• ≥3 terminations
• Essential hypertension treated pre-pregnancy
• Moderate-severe hypertension at booking ≥160/100 mmHg
• Diabetes
• Renal disease
• Systemic lupus erythematosus
• Anti-phospholipid syndrome
• Sickle cell disease
• HIV positive
• Major uterine anomaly
• Cervical suture
• Knife cone biopsy
• Ruptured membranes now
• Long term steroids
• Treatment low-dose aspirin
• Treatment calcium (>1g/24h)
• Treatment eicosapentanoic acid (fish oil)
• Treatment vitamin C ≥1000 mg & Vit E ≥400 iu
• Treatment heparin/low molecular weight heparin

The study population is the ones selected by the SCOPE Study in New Zealand

Test validation of the screening technique will be conducted blinded. The investigators will have access only to the serum samples identified by their unique ID. At the end of the analytical phase, the database containing results will be locked. The database will be transferred to an independent investigator (Prof. Alessio Fasano at Mass General Hospital for Children, Boston, USA) for data analysis. At the same time, information related to pregnancy outcomes (in terms of presence or absence of fetal anomaly) will be transferred from the University of Auckland to the Mass General Hospital for Children, which will provide the blind break and will procced to the estimation of the test performance.