Clinical trial NCT03552055: Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation
Official title: Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Age
Keywords: placental proteins
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Planned Parenthood of Southeastern Pennsylvania
First posted: 2018-06-11
Enrollment: 245
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.

Eligibility 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

Primary outcomes:
measure: protein concentration
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Planned Parenthood of Southeastern Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Gynuity Health Project
name: Elizabeth Raymond
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raymond EG, Frye LJ, Weaver MA, Lebed JP, Ren X, Steider E, Winikoff B, Barnhart KT. Sensitivity and specificity of placental proteins for gestational age screening: An exploratory study. Contraception. 2020 May;101(5):309-314. doi: 10.1016/j.contraception.2020.01.007. Epub 2020 Feb 1.