Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays

Completed

• Conditions: Trisomy 18 in Fetus; Trisomy 21 in Fetus; Trisomy 13 in Fetus

• Registration Number: NCT03629795
• Lead Sponsor: Axis Shield Diagnostics Ltd

Brief Summary

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Detailed Description

Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Study Timeline

• Study Start: 2017-11-17
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Study First Submitted: 2018-07-26
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:

  1. Subject is ≥ 18 years of age
  2. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
  3. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm

Exclusion Criteria

• A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:

  1. Subject is unable to give consent
  2. Subject has already participated in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sample handling	3 months	Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.

Trial Locations

Locations (1)

Newcastle University; 🇬🇧 Newcastle Upon Tyne, UK, United Kingdom