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Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03552055
Enrollment
245
Registered
2018-06-11
Start date
2017-05-24
Completion date
2019-09-30
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Age

Keywords

placental proteins

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.

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.

Interventions

OTHERNon-interventional Study

no interventions in this study, just specimen collection

Sponsors

University of Pennsylvania
CollaboratorOTHER
Planned Parenthood of Southeastern Pennsylvania
CollaboratorUNKNOWN
Gynuity Health Projects
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE

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

Design outcomes

Primary

MeasureTime frameDescription
protein concentration1 dayConcentration of placental proteins in blood and urine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026