NCT07610590|Recruiting
guideSEQ: Genomic Understanding, Impact, Decision & Ethics in Prenatal Sequencing
guideSEQ
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guideSEQ
Sponsor study identifier
Secondary identifiers
interventional
1,042
1 country
3
Study Start
April 29, 2026
Actual (reported)Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study looks at whether genome sequencing should be used more routinely during pregnancy, even when ultrasounds look normal. Genome sequencing can examine nearly all of a baby's genes and may find genetic conditions that standard tests do not detect. Researchers will compare this test with current prenatal testing to see if it provides helpful information for families and doctors. The study will also explore how parents decide what kinds of genetic information they want to receive and how this information affects their experience during pregnancy. The goal is to understand whether genome sequencing can be used in a way that is helpful, responsible, and supportive for families in the future.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2026
Actual (reported)May 20, 2026
Actual (reported)May 28, 2026
Actual (reported)July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incremental Genomic Frequency
The incremental frequency of fetal genetic conditions identified and reported by genomic sequencing (GS) compared to those found by standard-of-care (SOC) testing, including pathogenic, likely pathogenic, or variant of uncertain significance (VUS) variants identified by sequencing and deemed reportable by the Variant Adjudication Committee
Baseline to 12 months postpartum.
Frequency and type of pathogenic and likely pathogenic (P/LP) genomic findings by SOC and GS independently
Baseline to 12 months postpartum.
Percent and type of P/LP findings reported
Baseline to 12 months postpartum.
Percent of fetal P/LP findings requiring adjudication
Baseline to 12 months postpartum.
Turnaround time of SOC and GS testing
Baseline to 12 months postpartum.
Frequency of reportable genomic findings in mother
Baseline to 12 months postpartum.
Genome sequencing (GS) is a genetic test that involves reading the genome to identify genetic changes (also known as "genetic variants") that can cause differences in human development and disease.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
New York Genome Center
New York, New York, 10013, United States
Columbia University Irving Medical Center (CUIMC)
New York, New York, 10032, United States
Ronald Wapner, MD
Columbia University Irving Medical Center (CUIMC)
First Submitted
May 20, 2026
First Posted
May 28, 2026
Study Start
April 29, 2026
Actual (reported)Primary Completion
July 31, 2029
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 15, 2026
Record last verified: 2026-05
In accordance with the NIH Genomic Data Sharing policy, sequencing data and clinical data will be shared with other scientific investigators.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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