PreeclampsiaNCT02780414
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
An observational study of Preeclampsia and Hypertension, run by Progenity, Inc. at 20 sites in United States.
Trial summary
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Hypertension, Proteinuria
- How many people
- 1,730 participants
- Where
- 20 sitesUnited States
- Study dates
- Jan 2016to 23 Oct 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: Pregnant women 18 to 45 years of age and 28 0/7 to 36 6/7 weeks gestational age with a singleton fetus presenting to clinic/triage/Labor \& Delivery for evaluation of, but not limited to, one or more of the following: * new onset elevated blood pressure * pre-existing hypertension * new onset proteinuria or worsening of pre-existing proteinuria * other organ system findings including thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, and cerebral or visual symptoms
Who may be able to join
- Subject is willing to provide informed consent and comply with study procedures
- 18 to 45 years of age
- Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American Congress of Obstetricians and Gynecologists (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 either: New onset elevated blood pressure in otherwise normotensive patient, worsening hypertension in a patient with pre-existing hypertension, new onset proteinuria or worsening of pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out Pre-E.
- Subject is willing to provide informed consent and comply with study procedures
- 18 to 45 years of age
- 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 diagnosed with Pre-E using 2013 ACOG guidelines
Who cannot join
- Pregnancy is non-viable or absence of fetal cardiac activity
- Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with severe features including: persistent severe hypertension (systolic ≥160 or diastolic ≥110; thrombocytopenia <100,000; liver enzymes 2x above upper normal limit or >70 with severe persistent right upper quadrant (RUQ) or epigastric pain, new development of renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual disturbances.
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
- Eligibility criteria for the POSITIVE CONTROL group:
- Pregnancy is non-viable or absence of cardiac activity
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Colorado
Aurora, Colorado, 80045
Austin Maternal Fetal Medicine
Austin, Texas, 78758
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Center of Research in Women's Health
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7516
Regional Obstetrical Consultants, PC
Chattanooga, Tennessee, 37403
Northwestern
Chicago, Illinois, 60611
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Geisinger Medical Center
Danville, Pennsylvania, 17822
Duke University
Durham, North Carolina, 27705
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
UT Health Medical School
Houston, Texas, 77030
Indiana University Health Physicians Women's Health
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Medical College of Wisconsin - Department of Obstetrics & Gynecology
Milwaukee, Wisconsin, 53226
Winthrop Clinical Trials Center
Mineola, New York, 11501
Yale Medical
New Haven, Connecticut, 06520
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Utah Hospital, OB/GYN Dept.
Salt Lake City, Utah, 84132
Washington Univ School of Medicine - Dept of OB-GYN
St Louis, Missouri, 63111
About this study
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method has emerged that more accurately identifies women at risk for preeclampsia, warranting improvements in diagnosing Pre-E.
This sample collection study will obtain serum and urine samples from pregnant women who present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of Pre-E.
Read the detailed description
Eligible subjects will provide written informed consent after which demographic and baseline clinical data will be recorded.
Collection of whole blood and urine samples will be performed at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.
Interim study visits will continue every 14 days [+/- 3 days] until the subject either: 1) reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up.
In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive control cases.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function
- Keywords
- Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema
- Medical subject headings
- Pre-Eclampsia, Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Liver Diseases, Pulmonary Edema
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 |
|---|---|---|
| Study Cohort | A group of at least 1,541 pregnant women with NO Pre-E diagnosis | |
| Positive Pre-E Control | A group of at least 250 pregnant women diagnosed with Pre-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected and Pre-E cases determined by institutional standards
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startJan 2016
- Primary completion29 Sep 2020
- Study completion23 Oct 2020
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
- Family based
- Time perspective
- Prospective
- Enrolment
- 1,730 participants (actual)
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
- NCT02780414
- Sponsor's protocol ID
- PRO-104-PREECLAMPSIA
- Status last verified
- Mar 2022
- First submitted
- 12 May 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Costantine MM, Sibai B, Bombard AT, Sarno M, West H, Haas DM, Tita AT, Paidas MJ, Clark EAS, Boggess K, Grotegut C, Grobman W, Su EJ, Burd I, Saade G, Chavez MR, Paglia MJ, Merriam A, Torres C, Habli M, Macones G, Wen T, Bofill J, Palatnik A, Edwards RK, Haeri S, Oberoi P, Mazloom A, Cooper M, Lockton S, Hankins GD. Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia. Hypertension. 2022 Jul;79(7):1515-1524. doi: 10.1161/HYPERTENSIONAHA.122.19038. Epub 2022 May 12.
PubMed 35545947
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
- ClinicalTrials.gov ID
- NCT02780414
- Acronym / sponsor ID
- PRO-104-PREECLAMPSIA
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function
- Keywords
- Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,730 participants (actual)
- Lead sponsor
- Progenity, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 23 May 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.
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method has emerged that more accurately identifies women at risk for preeclampsia, warranting improvements in diagnosing Pre-E.
This sample collection study will obtain serum and urine samples from pregnant women who present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of Pre-E.
Detailed description
Eligible subjects will provide written informed consent after which demographic and baseline clinical data will be recorded.
Collection of whole blood and urine samples will be performed at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.
Interim study visits will continue every 14 days [+/- 3 days] until the subject either: 1) reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up.
In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive control cases.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –A group of at least 1,541 pregnant women with NO Pre-E diagnosis |
| Positive Pre-E Control | – | –A group of at least 250 pregnant women diagnosed with Pre-E |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women 18 to 45 years of age and 28 0/7 to 36 6/7 weeks gestational age with a singleton fetus presenting to clinic/triage/Labor \& Delivery for evaluation of, but not limited to, one or more of the following: * new onset elevated blood pressure * pre-existing hypertension * new onset proteinuria or worsening of pre-existing proteinuria * other organ system findings including thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, and cerebral or visual symptoms
Key inclusion criteria (8 listed)
- Subject is willing to provide informed consent and comply with study procedures
- 18 to 45 years of age
- Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American Congress of Obstetricians and Gynecologists (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 either: New onset elevated blood pressure in otherwise normotensive patient, worsening hypertension in a patient with pre-existing hypertension, new onset proteinuria or worsening of pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out Pre-E.
- Subject is willing to provide informed consent and comply with study procedures
Key exclusion criteria (8 listed)
- Pregnancy is non-viable or absence of fetal cardiac activity
- Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with severe features including: persistent severe hypertension (systolic ≥160 or diastolic ≥110; thrombocytopenia <100,000; liver enzymes 2x above upper normal limit or >70 with severe persistent right upper quadrant (RUQ) or epigastric pain, new development of renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual disturbances.
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
- Pregnancy is non-viable or absence of cardiac activity
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
Suspected and Pre-E cases determined by institutional standards
Time frame: about 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 11 Mar 2022.
- Derived from this study: PubMed 35545947Costantine MM, Sibai B, Bombard AT, Sarno M, West H, Haas DM, Tita AT, Paidas MJ, Clark EAS, Boggess K, Grotegut C, Grobman W, Su EJ, Burd I, Saade G, Chavez MR, Paglia MJ, Merriam A, Torres C, Habli M, Macones G, Wen T, Bofill J, Palatnik A, Edwards RK, Haeri S, Oberoi P, Mazloom A, Cooper M, Lockton S, Hankins GD. Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia. Hypertension. 2022 Jul;79(7):1515-1524. doi: 10.1161/HYPERTENSIONAHA.122.19038. Epub 2022 May 12.
- 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.
20 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 and Hypertension, run by Progenity, Inc. at 20 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 8 inclusion and 8 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Suspected and Pre-E cases determined by institutional standards (time frame: about 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 NCT02780414, 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 11 Mar 2022.