Gestational AgeNCT03552055
Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation
An observational study of Gestational Age, run by Gynuity Health Projects at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Age
- What is being tested?
- Non-interventional Study
- How many people
- 245 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2017to 30 Sep 2019
- 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 women
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Planned Parenthood of Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Gestational Age
- Being tested
- Non-interventional Study
- Keywords
- placental proteins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional StudyOther
no interventions in this study, just specimen collection
What is being measured
The primary outcome is the main question the study is designed to answer.
protein concentration
Concentration of placental proteins in blood and urine
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 posted11 Jun 2018
- Study start24 May 2017
- Primary completion30 Mar 2018
- Study completion30 Sep 2019
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 Gestational AgeStudies 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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Planned Parenthood of Southeastern Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Elizabeth Raymond, Principal investigator, Gynuity Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552055
- Sponsor's protocol ID
- 8000
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2017
- 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
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.
PubMed 32014519
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
- Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation
- ClinicalTrials.gov ID
- NCT03552055
- Acronym / sponsor ID
- 8000
- Conditions
- Gestational Age
- Keywords
- placental proteins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Planned Parenthood of Southeastern Pennsylvania
- Study start
- 24 May 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Jun 2018 (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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Non-interventional Studyno interventions in this study, just specimen collection | Other | – |
Primary outcome
protein concentration
Time frame: 1 day
Concentration of placental proteins in blood and urine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Background: PubMed 32014519Raymond 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.
- 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 Raymond principal investigator
Gynuity Health Project
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age, run by Gynuity Health Projects at 2 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 7 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: finished, 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 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
protein concentration (time frame: 1 day). 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 NCT03552055, 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.