Proteomic Assessment of Preterm Birth (PAPR)
This study is currently recruiting participants.
Verified August 2012 by Sera Prognostics, Inc.
Sponsor:
Sera Prognostics, Inc.
Information provided by (Responsible Party):
Sera Prognostics, Inc.
ClinicalTrials.gov Identifier:
NCT01371019
First received: June 8, 2011
Last updated: February 26, 2013
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 8, 2011 | ||||||||
| Last Updated Date | February 26, 2013 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Spontaneous Preterm Birth | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01371019 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Proteomic Assessment of Preterm Birth | ||||||||
| Official Title ICMJE | Proteomic Assessment of Preterm Birth | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Serum, plasma |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Pregnant women who are receiving prenatal care. |
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| Condition ICMJE | Preterm Birth | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| 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. 2010 Nov 11; [Epub ahead of print] | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 5000 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01371019 | ||||||||
| Other Study ID Numbers ICMJE | Sera - 004 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Sera Prognostics, Inc. | ||||||||
| Study Sponsor ICMJE | Sera Prognostics, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sera Prognostics, Inc. | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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