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OpenTrials
Active, not recruiting

NCT Number: NCT06690099

Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Rhesus D Genotype Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ochsner Health

New Orleans, Louisiana, 70115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide written informed consent
  • 18 years of age or older at enrollment
  • Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age
  • Women with RhD negative antigen status by serology
  • Willing to provide neonatal ABO and RhD genotyping status

Exclusion criteria

  • Women with multiple gestation pregnancy

Treatment and study plan

Primary outcomes

  1. Fetal RhD determination from maternal whole blood

    Time frame: 18 months

    Collected samples will be used for future development of non-invasive prenatal test to determine fetal RhD status from maternal whole blood

Sponsors and collaborators

Lead sponsor

Devyser Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 15, 2024
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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