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Completed

NCT Number: NCT02965287

Validation of a Test for Fetal Malformations

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.

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Key information

Conditions

Fetal Anomaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Sex eligibility

Female

Study type

Observational

Primary location

Theoreo srl

Montecorvino Pugliano, Salerno, 84090, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum Metabolomics profiling

Other

The serum samples will be used to get a metabolomic profile

Primary outcomes

  1. Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation

    Time frame: 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

  2. Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 19-21 weeks' gestation

    Time frame: 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 outcomes

  1. Diagnostic test performance evaluation in dichotomic classification at 14-16 weeks gestation

    Time frame: 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

  2. Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 14-16 weeks gestation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Theoreo Srl

Industry

Collaborators

  • Auckland UniServices Ltd.
  • Massachusetts General Hospital

Registry information

Official study title

Blind Validation of a Metabolomics Based Test for the Non-invasive Screening of Fetal Malformations

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 16, 2016
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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