Trials / Terminated
TerminatedNCT04232189
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 275 (actual)
- Sponsor
- Gynuity Health Projects · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- —
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.
Detailed description
Knowledge of gestational age (GA) is essential for guiding abortion care. In 2016, Gynuity Health Projects (GHP) launched a portfolio of research that aims to explore the possibility of developing a blood or urine test for this purpose.The goal of the present study is to validate initial study findings (protocol 8000) in a larger population of people seeking abortion. Staff will obtain a serum specimen from each participant before any cervical manipulation is performed and before any abortifacient drug is administered. The site will send the specimens to a central facility for storage until assay. Serum assays for PAPP-A and possibly other proteins will be performed at a selected laboratory by qualified experts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | no intervention | no intervention, just specimen collection |
Timeline
- Start date
- 2019-11-12
- Primary completion
- 2020-04-14
- Completion
- 2020-04-14
- First posted
- 2020-01-18
- Last updated
- 2021-07-23
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04232189. Inclusion in this directory is not an endorsement.