NCT03552055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

April 20, 2017

Last Update Submit

July 19, 2021

Conditions

Gestational Age

Keywords

placental proteins

Outcome Measures

Primary Outcomes (1)

  • protein concentration

    Concentration of placental proteins in blood and urine

    1 day

Interventions

Non-interventional StudyOTHER

no interventions in this study, just specimen collection

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Planned Parenthood of Southeastern Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 32014519BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We will be collecting blood and urine specimens from participants for assay for five placental proteins.

Study Officials

  • Elizabeth Raymond

    Gynuity Health Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

June 11, 2018

Study Start

May 24, 2017

Primary Completion

March 30, 2018

Study Completion

September 30, 2019

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

US(2)