NCT06690099

Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Devyser Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to collect blood samples and data from pregnant women who are Rh negative. The blood will be used for the future research and the development of non-invasive prenatal tests to identify Rh blood type status of the baby during pregnancy.

Detailed description

This is a prospective multi-center blood collection study. Women 18 years of age or older with a viable singleton pregnancy between12 weeks and 28 weeks gestation will be enrolled. Whole blood samples will be collected from each enrolled patient. Maternal specimens will be processed to plasma and stored for future testing with non-invasive prenatal tests to identify fetal Rh status. Baby RhD blood type status will be recorded after delivery. All obstetric clinical management will take place per standard clinic practices and procedures and will not be altered by participation in the study.

Conditions

• Rhesus D Genotype
• Pregnancy

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-11-15
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States