Validation of a Test for Fetal Malformations

Fetal Anomaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965287
• Other study ID #: MV-01
• Status: Completed
• First received: November 14, 2016
• Last updated: March 20, 2018
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: Theoreo Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1943
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Anomaly

Intervention

Other:
• Serum metabolomics profiling
The serum samples will be used to get a metabolomic profile

Locations

Country	Name	City	State
Italy	Theoreo srl	Montecorvino Pugliano	Salerno

Sponsors (3)

Lead Sponsor	Collaborator
Theoreo Srl	Auckland UniServices Ltd., Massachusetts General Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

McCowan LM, Thompson JM, Taylor RS, North RA, Poston L, Baker PN, Myers J, Roberts CT, Dekker GA, Simpson NA, Walker JJ, Kenny LC; SCOPE Consortium. Clinical prediction in early pregnancy of infants small for gestational age by customised birthweight centiles: findings from a healthy nulliparous cohort. PLoS One. 2013 Aug 5;8(8):e70917. doi: 10.1371/journal.pone.0070917. Print 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation	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	6 months
Primary	Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 19-21 weeks' gestation	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	6 months
Secondary	Diagnostic test performance evaluation in dichotomic classification at 14-16 weeks gestation	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	6 months
Secondary	Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 14-16 weeks gestation	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	6 months