PregnancyNCT04232189
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion
An observational study of Pregnancy, run by Gynuity Health Projects at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- How many people
- 275 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2019to 14 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.
Who may be able to join
- 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
Who cannot join
- Does not meet Inclusion Criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Family Planning Associates
Chicago, Illinois, 60661
Planned Parenthood of New York City
New York, New York, 10012
Presidential Women's Center
West Palm Beach, Florida, 33407
About this study
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.
Read the 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
- Pregnancy
- Being tested
- no intervention
- Keywords
- placental protein, gestational age, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, just specimen collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value 70 days
Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is >95%
Measured: 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%
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Nov 2019
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Why it stopped: COVID 19 related recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Family Planning Associates Medical Group, LTD, Planned Parenthood of Greater New York, Presidential Women's Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth G Raymond, MD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232189
- Sponsor's protocol ID
- 8003
- Status last verified
- Jul 2021
- First submitted
- 14 Jan 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37038980
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion
- ClinicalTrials.gov ID
- NCT04232189
- Acronym / sponsor ID
- 8003
- Conditions
- Pregnancy
- Keywords
- placental protein, gestational age, abortion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID 19 related recruitment problems
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Family Planning Associates Medical Group, LTD, Planned Parenthood of Greater New York, Presidential Women's Center
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention, just specimen collection | Other | – |
Primary outcome
Negative Predictive Value 70 days
Time frame: 1 day
Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is >95%
Negative Predictive Value 105 days
Time frame: 1 day
Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤105 days is >95%
Results and safety
The study was stopped early (reason given: COVID 19 related recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Derived from this study: PubMed 37038980Frye 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth G Raymond, MD principal investigator
Gynuity Health Projects
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Gynuity Health Projects at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID 19 related recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Predictive Value 70 days (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.