Early PrEgnancy Complications Testing

NCT04079361 | Recruiting

• 1 other identifier: EC/2019/0056
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (2)

• Optimizing and validating a non-invasive prenatal genetic screening for the early presymptomatic detection of pregnancy complications

  The placental transcriptome represents gene expression in this specific tissue. Abnormalities in the placenta have been shown to lead to aberrant gene expression patterns. The RNA biomarker (transcript) analysis will be performed by RNA sequencing of cell free RNA by next generation sequencing. After sequencing, RNA molecules will be identified and transcripts will be quantified and evaluated between normal and pregnancies with complications. This will provide information regarding aberrant expressed genes and transcripts. Statistical analysis between both groups will be performed to identify and subsequently validate biomarkers that can be used to presymptomatically prediction pregnancy complications.

  Through study completion, an average of 30 weeks

• Optimizing and validating a non-invasive prenatal genetic screening for the early presymptomatic detection of pregnancy complications

  Epigenetic modifications (eg. DNA methylation) can alter gene expression, without altering the DNA sequence itself. DNA methylation can be investigated by bisulfite conversion of the DNA followed by next-generation sequencing. It has been shown that complicated pregnancies have aberrant methylation profiles of placental DNA. By analyzing the methylation profile of the cell free DNA of normal and complicated pregnancies and performing a statistical analysis, we will identify biomarkers and set-up a prediction model for the prediction of pregnancy complication.

  Through study completion, an average of 30 weeks

Study Arms (1)

Pregnancy complication

OTHER

Intervention: blood samples

Diagnostic Test: Blood samples

Interventions

Blood samples DIAGNOSTIC_TEST

Bood samples during prenatal and postnatal visits

Pregnancy complication

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Every pregnant woman, speaking and understanding Dutch, French or English

You may not qualify if:

• not able to understand and adhere to the informed consent and study procedures

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital - Women's Clinic

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Isabelle Dehaene, MD

  UZ Gent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Dehaene, MD

CONTACT

003293327817; isabelle.dehaene@uzgent.be

Eline Meireson, MSc

CONTACT

eline.meireson@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: September 6, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)