Pre-EclampsiaNCT03767803
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
An observational study of Pre-Eclampsia and Hypertension, run by Progenity, Inc. at 24 sites in United States.
Trial summary
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy
- What is being tested?
- Non-interventional study
- How many people
- 344 participants
- Where
- 24 sitesUnited States
- Study dates
- 1 Oct 2018to 31 Dec 2020
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
Who may be able to join
- Subject is 18 to 45 years of age
- Subject is willing to provide informed consent
- Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician able to provide 20 mL of whole blood and will comply with all study procedures
- Subject has a singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
- Patient presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:
- New onset increased blood pressure in otherwise normotensive patient
Show all 9Show fewer
- Worsening hypertension in a patient with pre-existing hypertension
- New onset proteinuria or worsening of pre-existing proteinuria
- Any other clinical finding typically associated with suspicion of Pre-E and requiring workup to rule-out Pre-E
Who cannot join
- Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Aa Ob-Gyn, Pllc
Austin, Texas, 78758
OB-GYN North
Austin, Texas, 78758
Women's Health Partners, LLC
Boca Raton, Florida, 33433
New Life Medical Esthetics and Wellness, PLLC
Brooklyn, New York, 11220
David B. Schwartz, MD, LLC
Cincinnati, Ohio, 45219
Corpus Christi Women's Clinic
Corpus Christi, Texas, 78412
Total Woman Care
Elkin, North Carolina, 28621
Obstetrics & Gynecology Associates, Inc.
Fairfield, Ohio, 45014
Hilltop Obstetrics & Gynecology
Franklin, Ohio, 45005
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Norton Healthcare
Louisville, Kentucky, 40202
Dr. Ahuja and Associates OB-GYN
Mentor, Ohio, 44060
Rutgers-RWJMS
New Brunswick, New Jersey, 08901
St. Peter's University Hospital
New Brunswick, New Jersey, 08901
Columbia University
New York, New York, 10032
Christiana Care
Newark, Delaware, 19718
Drexel University
Philadelphia, Pennsylvania, 19102
Discovery Clinical Research
Plantation, Florida, 33324
Valley OB-GYN Clinic, PC
Saginaw, Michigan, 48602
Advanced Clinical Research
Salt Lake City, Utah, 84107
West Coast Medical Research, Inc.
San Diego, California, 92123
Obstetrics and Gynecology Associates AMB
Silver Spring, Maryland, 20910
Virtua Voorhees Hospital
Voorhees Township, New Jersey, 08043
About this study
Official title: Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
Read the detailed description
This multicenter non-interventional observational sample acquisition study is designed to acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as outpatient centers, clinic sites, and medical offices.
Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
- Conditions
- Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function
- Being tested
- Non-interventional study
- Keywords
- Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema, Cerebral Symptoms, Visual Symptoms
- Medical subject headings
- Pre-Eclampsia, Hypertension, Thrombocytopenia, Renal Insufficiency, Liver Diseases, Pulmonary Edema, Headache, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
This is an observational, non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Positive Preeclampsia group | A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery Receives: Other: Non-interventional study | |
| Study Cohort | A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery. Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of preeclampsia is determined by standard of care.
Observational, non-interventional sample procurement study in which participants are treated per standard of care
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progenity, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Stiegler, PhD, Study director, Progenity, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767803
- Sponsor's protocol ID
- PRO-129-PREECLAMPSIA
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
- ClinicalTrials.gov ID
- NCT03767803
- Acronym / sponsor ID
- PRO-129-PREECLAMPSIA
- Conditions
- Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function
- Keywords
- Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema, Cerebral Symptoms, Visual Symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Progenity, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Dec 2018 (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.
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
Detailed description
This multicenter non-interventional observational sample acquisition study is designed to acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as outpatient centers, clinic sites, and medical offices.
Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Preeclampsia group | – | Other: Non-interventional studyA group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery |
| Study Cohort | – | Other: Non-interventional studyA group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
Key inclusion criteria (9 listed)
- Subject is 18 to 45 years of age
- Subject is willing to provide informed consent
- Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician able to provide 20 mL of whole blood and will comply with all study procedures
- Subject has a singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
- Patient presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:
Key exclusion criteria (3 listed)
- Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
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 |
|---|---|---|
| Non-interventional studyThis is an observational, non-interventional study. | Other | Positive Preeclampsia group, Study Cohort |
Primary outcome
Diagnosis of preeclampsia is determined by standard of care.
Time frame: 3 months
Observational, non-interventional sample procurement study in which participants are treated per standard of care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Peter Stiegler, PhD study director
Progenity, Inc.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia and Hypertension, run by Progenity, Inc. at 24 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 9 inclusion and 3 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 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Results are not available in the source record.
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?
Diagnosis of preeclampsia is determined by standard of care. (time frame: 3 months). 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 23 Jan 2020.