Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-07

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Rhesus D Genotype Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

Pregnant women who are RhD negative and between 12 and 28 weeks gestation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Willing and able to provide written informed consent
2. 18 years of age or older at enrollment
3. Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age
4. Women with RhD negative antigen status by serology
5. Willing to provide neonatal ABO and RhD genotyping status