Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : June 11, 2018
Last Update Posted : July 23, 2021
Sponsor:
Collaborators:
University of Pennsylvania
Planned Parenthood of Southeastern Pennsylvania
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Investigators will collect serum and urine specimens from pregnant patients along the full pregnancy continuum, assay each specimen for selected placental proteins, and examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

Condition or disease Intervention/treatment
Gestational Age Other: Non-interventional Study

Detailed Description:

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 245 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Non-interventional Study
    no interventions in this study, just specimen collection

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. protein concentration [ Time Frame: 1 day ]
    Concentration of placental proteins in blood and urine


Biospecimen Retention:   Samples With DNA
We will be collecting blood and urine specimens from participants for assay for five placental proteins.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

Inclusion Criteria:

  • Has an intrauterine pregnancy confirmed by ultrasound
  • Not known to have pregnancy-induced hypertension (preeclampsia) or diabetes
  • Not known to have a nonviable pregnancy, a multiple pregnancy, a pregnancy with a chromosomal or fetal abnormality, or a pregnancy with growth restriction
  • Not currently taking anticoagulants
  • Not currently having clinically significant vaginal bleeding, unusual pelvic pain, or other symptom suggestive of a pregnancy complication
  • No use of assisted reproductive technology to conceive the current pregnancy
  • Not previously enrolled in this study

Exclusion Criteria:

  • Does not meet inclusion criteria
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Planned Parenthood of Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Gynuity Health Projects
University of Pennsylvania
Planned Parenthood of Southeastern Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Raymond Gynuity Health Project
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03552055    
Other Study ID Numbers: 8000
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gynuity Health Projects:
placental proteins