NCT04232189

Brief Summary

This will be a case-series multicenter study enrolling 800 pregnant people. Serum will be collected from people seeking abortion and assayed at a qualified laboratory.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

Study Start

First participant enrolled

November 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2020

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

January 14, 2020

Last Update Submit

July 19, 2021

Conditions

Pregnancy

Keywords

placental proteingestational ageabortion

Outcome Measures

Primary Outcomes (2)

  • Negative Predictive Value 70 days

    Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is \>95%

    1 day

  • Negative Predictive Value 105 days

    Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤105 days is \>95%

    1 day

Interventions

no interventionOTHER

no intervention, just specimen collection

Eligibility Criteria

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

Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.

You may qualify if:

  • Pregnant and seeking medical or surgical abortion
  • Has had or will have an ultrasound on the day of study enrollment or earlier during the current pregnancy
  • Able to provide blood and urine specimens before any trans-cervical procedure or mifepristone ingestion
  • Not previously enrolled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Presidential Women's Center

West Palm Beach, Florida, 33407, United States

Location

Family Planning Associates

Chicago, Illinois, 60661, United States

Location

Planned Parenthood of New York City

New York, New York, 10012, United States

Location

Related Publications (1)

  • Frye LJ, Buhimschi IA, Raymond EG, Zhao G, Winikoff B. PAPP-A as a screening tool for assessment of gestational age before medication abortion in an intended-use population. Biomark Med. 2023 Jan;17(2):73-85. doi: 10.2217/bmm-2022-0653. Epub 2023 Apr 11.

    PMID: 37038980DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine

Study Officials

  • Elizabeth G Raymond, MD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

November 12, 2019

Primary Completion

April 14, 2020

Study Completion

April 14, 2020

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

US(3)