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Completed

NCT Number: NCT03552055

Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood of Southeastern Pennsylvania, Philadelphia, Pennsylvania, United States

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About this 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

no interventions in this study, just specimen collection

Primary outcomes

  1. protein concentration

    Time frame: 1 day

    Concentration of placental proteins in blood and urine

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Planned Parenthood of Southeastern Pennsylvania
  • University of Pennsylvania

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 11, 2018
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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