A Pilot Study for Implementation of First Trimester Screening of Aneuploidies in Campania Region

NCT05798858 | Unknown

• 1 other identifier: 438/21
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare two different protocols for first trimester screening of aneuploidies, one based on nuchal translucency and NIPT and another one based on the integration between combined test and NIPT, in order to identify which is the most adequate for the Campania region. In particular, a cost-benefit comparison will be made which will take into account for each method:

• Actual costs;
• Percentage of patients who agree to undergo the proposed screening and number of patients who undergo extra tests not included in the screening protocol;
• Post-invasive procedure miscarriage rate;
• False positives (fetuses undergoing an invasive procedure for a positive screen, which have a normal karyotype).

Conditions

Aneuploidy

Keywords

aneuploidy; screening; combined test; non invasive prenatal testing

Outcome Measures

Primary Outcomes (1)

• compliance to the screening

  percentage of patients not performing test not included in arm protocol

  up to 9 months

Secondary Outcomes (3)

• spontaneous abortions

  up to seven days

• sensitivity and specificity of two protocols

  up to 9 months

• total costs

  up to 3 months

Study Arms (2)

Group A: NT+ NIPT

ACTIVE COMPARATOR

Group A patients will undergo NT between 11+3 and 13+6 weeks. If the NT is \<3.5 mm, the patient will be offered to continue the screening with NIPT. If NIPT comes back as positive result, the result will be confirmed by an invasive procedure (amniocentesis/villocentesis); if, on the other hand, the NIPT will give a negative result, the screening is concluded and the patient will not undergo further tests.

Diagnostic Test: NIPT

Group B

ACTIVE COMPARATOR

Combined test + NIPT (n=200) The patients of group A will undergo NT between 11+3 and 13+6 weeks, according to the same protocol foreseen for Group A. If the NT is \<3.5 mm, the patient will be offered continuation of the screening using the combined test. In case of: High risk (1:2-1:100), the patient will be offered an invasive procedure (amniocentesis/villocentesis) Intermediate risk (1:101-1:1000), the patient will be offered NIPT, according to the protocol already described for Group A. In the event of a positive result, the patient will undergo an invasive procedure (amniocentesis/villocentesis ); in the case of negative NIPT, the screening is concluded and the patient will not undergo further tests. Low risk (\>1:1000), screening ends and the patient will not undergo further tests.

Diagnostic Test: NIPT

Interventions

NIPT DIAGNOSTIC_TEST

universal nipt in group a, NIPT for intermediate risk in Group B

Group A: NT+ NIPT; Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• all patients referred to our hospital for first trimester screening scan

You may not qualify if:

• maternal age\<18
• twin pregnancies
• lack of a signed consent form

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Aneuploidy

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Researcher

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 5, 2023
• Study Start: January 11, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)