Pregnancy ComplicationsExPECTNCT04079361
Early PrEgnancy Complications Testing
A study testing Blood samples in people with Pregnancy Complications, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Every pregnant woman, speaking and understanding Dutch, French or English
Who cannot join
- not able to understand and adhere to the informed consent and study procedures
Trial locations and contacts
1 site in 1 country.
Eline Meireson, MSc contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital - Women's Clinic
Ghent, 9000
Sara Somers, Sara.Somers@uzgent.be
About this study
Official title: Non-invasive Prenatal Testing for the Presymptomatic Detection of Pregnancy Complications
The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment.
Read the detailed description
Prenatal screening for an early detection of fetal abnormalities and pregnancy related complications is of great importance for both the fetus and the mother. The current follow-up consists of a physical screening (maternal blood pressure, edemas, weight, fundus altitude...), lab screenings (urine culture for screening asymptomatic bladder infection, urine stick for preeclampsia, sugar test for gestational diabetes, measuring cervix length for premature birth, Group B streptococcus screening), ultrasound monitoring (structural inspection, biometrics, placental function ...) and fetal monitoring with cardiotocography.
The recent introduction of the Non-Invasive Prenatal Testing (NIPT) caused a major change in prenatal diagnosis. NIPT allows the early (12 weeks gestational age) detection of chromosomal abnormalities, such as trisomy 21, with a very high sensitivity and specificity.
Trisomy 21 is with its incidence of 1/1000 live births only the tip of the iceberg of many other fetal abnormalities and gestational complications that can occur. Pregnancy complications, such as pre-eclampsia, intra-uterine growth retardation (IUGR) and preterm birth have a much higher incidence (up to 5-8% of all pregnancies) and are an important cause of maternal and neonatal morbidity and mortality.
The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment. Studies have shown that the major cause of these complications originate from defects in spiral artery remodeling and trophoblast invasion or an abnormal functioning placenta, during the 1st or 2nd trimester. Insufficient oxygen and nutrient flow to the placenta, caused by abnormal (narrowed diameter) spiral arteria, is the most proven underlying origin. These obstructing conditions can lead to a placenta in stress (hypoxia), and therefore potentially a fetus in stress (IUGR). General known is that these pathologies will lead to a different gene expression, which can be investigated by direct analysis of placental RNA (transcriptome) and DNA (methylation profiling). During the last decade, several high impact researchers (for example the research groups of Dennis Lo and Stephen Quake, founders of the current worldwide NIPT screening) have investigated gene expression profiles in the placenta in normal and complicated pregnancies, by analyzing the placental cell free DNA and RNA present in maternal plasma. Very recent findings indicate a huge potential in non-invasively profiling the placental transcriptome and methylome. Advances in next-generation sequencing and molecular analysis made it possible to measure circulating nucleic acids to improve the investigator's understanding of placental pathology and develop novel non-invasive biomarkers for pregnancy complications and monitoring high-risk pregnancies.
- Conditions
- Pregnancy Complications
- Being tested
- Blood samples
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
Bood samples during prenatal and postnatal visits
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy complication | Other | Intervention: blood samples Receives: Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Dehaene, MD, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079361
- Sponsor's protocol ID
- EC/2019/0056
- Acronym
- ExPECT
- Status last verified
- Sep 2024
- First submitted
- 1 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Prenatal Testing for the Presymptomatic Detection of Pregnancy Complications
- ClinicalTrials.gov ID
- NCT04079361
- Acronym / sponsor ID
- ExPECT / EC/2019/0056
- Conditions
- Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment.
Detailed description
Prenatal screening for an early detection of fetal abnormalities and pregnancy related complications is of great importance for both the fetus and the mother. The current follow-up consists of a physical screening (maternal blood pressure, edemas, weight, fundus altitude...), lab screenings (urine culture for screening asymptomatic bladder infection, urine stick for preeclampsia, sugar test for gestational diabetes, measuring cervix length for premature birth, Group B streptococcus screening), ultrasound monitoring (structural inspection, biometrics, placental function ...) and fetal monitoring with cardiotocography.
The recent introduction of the Non-Invasive Prenatal Testing (NIPT) caused a major change in prenatal diagnosis. NIPT allows the early (12 weeks gestational age) detection of chromosomal abnormalities, such as trisomy 21, with a very high sensitivity and specificity.
Trisomy 21 is with its incidence of 1/1000 live births only the tip of the iceberg of many other fetal abnormalities and gestational complications that can occur. Pregnancy complications, such as pre-eclampsia, intra-uterine growth retardation (IUGR) and preterm birth have a much higher incidence (up to 5-8% of all pregnancies) and are an important cause of maternal and neonatal morbidity and mortality.
The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment. Studies have shown that the major cause of these complications originate from defects in spiral artery remodeling and trophoblast invasion or an abnormal functioning placenta, during the 1st or 2nd trimester. Insufficient oxygen and nutrient flow to the placenta, caused by abnormal (narrowed diameter) spiral arteria, is the most proven underlying origin. These obstructing conditions can lead to a placenta in stress (hypoxia), and therefore potentially a fetus in stress (IUGR). General known is that these pathologies will lead to a different gene expression, which can be investigated by direct analysis of placental RNA (transcriptome) and DNA (methylation profiling). During the last decade, several high impact researchers (for example the research groups of Dennis Lo and Stephen Quake, founders of the current worldwide NIPT screening) have investigated gene expression profiles in the placenta in normal and complicated pregnancies, by analyzing the placental cell free DNA and RNA present in maternal plasma. Very recent findings indicate a huge potential in non-invasively profiling the placental transcriptome and methylome. Advances in next-generation sequencing and molecular analysis made it possible to measure circulating nucleic acids to improve the investigator's understanding of placental pathology and develop novel non-invasive biomarkers for pregnancy complications and monitoring high-risk pregnancies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy complication | Other | Diagnostic Test: Blood samplesIntervention: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Every pregnant woman, speaking and understanding Dutch, French or English
Key exclusion criteria (1 listed)
- not able to understand and adhere to the informed consent and study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBood samples during prenatal and postnatal visits | Diagnostic test | Pregnancy complication |
Primary outcome
Optimizing and validating a non-invasive prenatal genetic screening for the early presymptomatic detection of pregnancy complications
Time frame: Through study completion, an average of 30 weeks
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.
Optimizing and validating a non-invasive prenatal genetic screening for the early presymptomatic detection of pregnancy complications
Time frame: Through study completion, an average of 30 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eline Meireson, MSc contact
Isabelle Dehaene, MD principal investigator
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Pregnancy Complications, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dehaene, MD (003293327817, isabelle.dehaene@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimizing and validating a non-invasive prenatal genetic screening for the early presymptomatic detection of pregnancy complications (time frame: Through study completion, an average of 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.