Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women

May 28, 2025 updated by: Devyser Inc.
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Exclusion Criteria:

1. Women with multiple gestation pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Devyser Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DVYUS-RHD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data with other researchers. Any shared data will be de-identified data at the cohort level in aggregate.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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