Preterm BirthPAPRNCT01371019
Proteomic Assessment of Preterm Birth
An observational study of Preterm Birth, run by Sera Prognostics, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Preterm Birth
- How many people
- 5,500 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2011to Apr 2015
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women who are receiving prenatal care.
Who may be able to join
- Subject is 18 years or older.
- Subject has a singleton pregnancy.
- Subject is able to provide consent.
Who cannot join
- Subject is pregnant with more than one fetus.
- There is a known or suspected fetal anomaly.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 25599-1651
Medical University of South Carolina
Charleston, South Carolina, 29425
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403
Ohio State University
Columbus, Ohio, 43210
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0156
Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street ,
Murray, Utah, 84107-5701
Christiana Care Health System
Newark, Delaware, 19713-4248
McKay-Dee Hospital Center
Ogden, Utah, 84403
Maricopa Integrated Health System
Phoenix, Arizona, 85008
Oregon Health and Science University
Portland, Oregon, 97239
LDS Hospital
Salt Lake City, Utah, 84143-0001
San Diego Perinatal Clinic
San Diego, California, 92123
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Proteomics
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| Women with preterm delivery | Not described | |
| Women without preterm delivery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Preterm Birth
Measured: August 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2014
- Study completionApr 2015
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 Preterm BirthStudies 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
- 5,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sera Prognostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Durlin E Hickok, MD, MPH, Study director, Sera Prognostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371019
- Sponsor's protocol ID
- Sera - 004
- Acronym
- PAPR
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2011
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Esplin MS, Merrell K, Goldenberg R, Lai Y, Iams JD, Mercer B, Spong CY, Miodovnik M, Simhan HN, van Dorsten P, Dombrowski M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth. Am J Obstet Gynecol. 2011 May;204(5):391.e1-8. doi: 10.1016/j.ajog.2010.09.021. Epub 2010 Nov 11.
PubMed 21074133
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Assessment of Preterm Birth
- ClinicalTrials.gov ID
- NCT01371019
- Acronym / sponsor ID
- PAPR / Sera - 004
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- Sera Prognostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jun 2011 (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.
The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with preterm delivery | – | – |
| Women without preterm delivery | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who are receiving prenatal care.
Key inclusion criteria (3 listed)
- Subject is 18 years or older.
- Subject has a singleton pregnancy.
- Subject is able to provide consent.
Key exclusion criteria (2 listed)
- Subject is pregnant with more than one fetus.
- There is a known or suspected fetal anomaly.
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
Spontaneous Preterm Birth
Time frame: August 2015
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 Jun 2015.
- Background: PubMed 21074133Esplin MS, Merrell K, Goldenberg R, Lai Y, Iams JD, Mercer B, Spong CY, Miodovnik M, Simhan HN, van Dorsten P, Dombrowski M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth. Am J Obstet Gynecol. 2011 May;204(5):391.e1-8. doi: 10.1016/j.ajog.2010.09.021. Epub 2010 Nov 11.
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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.
Durlin E Hickok, MD, MPH study director
Sera Prognostics, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Sera Prognostics, Inc. at 13 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 3 inclusion and 2 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 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Spontaneous Preterm Birth (time frame: August 2015). 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 NCT01371019, 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 Jun 2015.