PreeclampsiaNCT02808494
Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
An observational study of Preeclampsia, run by Illumina, Inc. at 10 sites in United States.
Trial summary
Sample Collection Study Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 242 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2016to 20 Nov 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Affected Group: Pregnant women diagnosed with preeclampsia with severe features or fetal growth restriction Control group: Pregnant women matched for gestational age to the Affected group above
Who may be able to join
- Women 18 years of age or older at enrollment
- Pregnant women with a viable singleton gestation
- Able to provide written, informed consent
- Able to provide 20 mL of whole blood
- Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
- Preeclampsia with severe features is defined as:
Show all 10Show fewer
- Proteinuria: Excretion of ≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated to the 24 hour urine value or a protein/creatinine [both in mg/dL] ratio of at least 0.3 or a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine >1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata
- Fetal Growth Restriction defined as:
- Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio >95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)
- Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines1. A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.
Who cannot join
- Known malignancy
- History of maternal organ or bone marrow transplant
- Maternal blood transfusion in the last 8 weeks
- Chronic hypertension diagnosed prior to current pregnancy
- Type I, II or gestational diabetes
- Fetal anomaly or known chromosome abnormality
- Active labor
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Tufts Medical Center
Boston, Massachusetts, 02111
New York-Presbyterian/Queens
Flushing, New York, 11355
The University of Texas Medical Branch
Galveston, Texas, 77555
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
Winthrop University Hospital Clinical Trials Center
New York, New York, 11501
Christiana Hospital
Newark, Delaware, 19718
Drexel Medicine
Philadelphia, Pennsylvania, 19102
Rutgers University
Piscataway, New Jersey, 08854
Virtua Materna-Fetal Medicine Specialists
Sewell, New Jersey, 08080
About this study
Official title: Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development
Sample Collection Study
Read the detailed description
This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Fetal Growth Restriction
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected Group | Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction. | |
| Control/Unaffected Group | Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMar 2016
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illumina, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Rhoa, MD, Study director, Illumina, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808494
- Sponsor's protocol ID
- RGH-014
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2016
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131.
PubMed 32611681
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development
- ClinicalTrials.gov ID
- NCT02808494
- Acronym / sponsor ID
- RGH-014
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Fetal Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Illumina, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
Sample Collection Study
Detailed description
This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected Group | – | –Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction. |
| Control/Unaffected Group | – | –Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Affected Group: Pregnant women diagnosed with preeclampsia with severe features or fetal growth restriction Control group: Pregnant women matched for gestational age to the Affected group above
Key inclusion criteria (10 listed)
- Women 18 years of age or older at enrollment
- Pregnant women with a viable singleton gestation
- Able to provide written, informed consent
- Able to provide 20 mL of whole blood
- Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
Key exclusion criteria (7 listed)
- Known malignancy
- History of maternal organ or bone marrow transplant
- Maternal blood transfusion in the last 8 weeks
- Chronic hypertension diagnosed prior to current pregnancy
- Type I, II or gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Results publication: PubMed 32611681Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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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.
Matthew Rhoa, MD study director
Illumina, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Illumina, Inc. at 10 sites in United States.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02808494, which also lists 1 linked publication.
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 29 Apr 2022.