Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03552055|
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment|
|Gestational Age||Other: Non-interventional Study|
Investigators will collect serum and urine specimens from pregnant patients along with ultrasound results and information about factors that may affect the concentrations of proteins or the estimation of gestational age. Investigators will obtain data across the full pregnancy continuum but we will over sample patients within five gestational weeks before and after the 10 week mark.
Investigators will assay each specimen for selected placental proteins (Human placental lactogen (HPL), Schwangerschaftsprotein 1 (SP1), Pregnancy-associated plasma protein A (PAPP-A), A Disintegrin and Metalloproteinase 12 (ADAM12), and Human chorionic gonadotropin (HGC)) and any other proteins of interest identified prior to running assays and will examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.
The goal is to identify at least one compound and a concentration threshold for that compound that can be used for differentiating pregnancies of less than 10 weeks in duration from later pregnancies.
|Study Type :||Observational|
|Actual Enrollment :||245 participants|
|Official Title:||Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation|
|Actual Study Start Date :||May 24, 2017|
|Actual Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||December 31, 2019|
- Other: Non-interventional Study
no interventions in this study, just specimen collection
- protein concentration [ Time Frame: 1 day ]Concentration of placental proteins in blood and urine
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552055
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Planned Parenthood of Southeastern Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Elizabeth Raymond||Gynuity Health Project|