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

NCT05798858 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-04-05

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

NIPT

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

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2023-12-31
Completion
2024-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05798858 on ClinicalTrials.gov