Clinical Trials Logo
  1. Home
  2. Preterm Birth
  3. NCT01371019
  4. Details
NCT01371019 Clinical Trial

Proteomic Assessment of Preterm Birth

Preterm Birth Clinical Trial

— PAPR  

Official title:
Proteomic Assessment of Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01371019
Other study ID # Sera - 004
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated June 9, 2015
Start date April 2011
Est. completion date April 2015

Study information
Verified date June 2015
Source Sera Prognostics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 5500
Est. completion date April 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Subject is 18 years or older.

- Subject has a singleton pregnancy.

- Subject is able to provide consent.

Exclusion Criteria:

- Subject is pregnant with more than one fetus.

- There is a known or suspected fetal anomaly.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Regional Obstetrical Consultants Chattanooga Tennessee
United States Ohio State University Columbus Ohio
United States University of Texas Medical Branch at Galveston Galveston Texas
United States Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street , Murray Utah
United States Christiana Care Health System Newark Delaware
United States McKay-Dee Hospital Center Ogden Utah
United States Maricopa Integrated Health System Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States LDS Hospital Salt Lake City Utah
United States San Diego Perinatal Clinic San Diego California
United States Baystate Medical Center Springfield Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Sera Prognostics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Spontaneous Preterm Birth August 2015 No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Completed NCT02993744 - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone N/A
Active, not recruiting NCT02673216 - Infection and Adverse Pregnancy Outcome
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT01412931 - Protein and Ultrasound Indicators of Preterm Birth N/A
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT02606058 - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? N/A
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Completed NCT00422526 - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial Phase 3
Enrolling by invitation NCT04251260 - Effectiveness of Positioning in Preterm Neonates N/A
Completed NCT03668860 - India Dexamethasone and Betamethasone Phase 1
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed NCT02225353 - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Phase 2
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Completed NCT03144141 - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery N/A
Completed NCT05210985 - Examination of the Relationship Between Home Affordances With Development
Completed NCT04021654 - What is the Future of Vulnerable New-borns