Fetal Anomaly
Conditions
Brief summary
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.
Detailed description
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.
Interventions
The serum samples will be used to get a metabolomic profile
Sponsors
Auckland UniServices Ltd.
Massachusetts General Hospital
Theoreo Srl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation | 6 months | Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of a malformed fetus through the analysis of a serum sample from a mother at 19-21 weeks' gestation |
| Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 19-21 weeks' gestation | 6 months | Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of the type of malformation through the analysis of a serum sample from a mother at 19-21 weeks' gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic test performance evaluation in dichotomic classification at 14-16 weeks gestation | 6 months | Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of a malformed fetus through the analysis of a serum sample from a mother at 19-21 weeks' gestation |
| Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 14-16 weeks gestation | 6 months | Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) in the identification of the type of malformation through the analysis of a serum sample from a mother at 14-16 weeks gestation |
Countries
Italy
Outcome results
None listed