Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Completed

• Conditions: Gestational Age

• Registration Number: NCT03552055
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study First Submitted: 2017-04-20
• Study Start: 2017-05-24
• Primary Completion: 2018-03-30
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-11
• Study Completion: 2019-09-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 245

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
protein concentration	1 day	Concentration of placental proteins in blood and urine

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Planned Parenthood of Southeastern Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States