Proteinuria in PregnancyNCT05434845
The Effect of Blood on the PC Ratio During Pregnancy
A study testing Blood draw in people with Proteinuria in Pregnancy, run by Marshall University at 1 site in United States.
Trial summary
This study will examine the effect if blood on the the protein to creatine (PC) ratio in pregnant patients by adding blood to urine samples. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Proteinuria in Pregnancy
- What is being tested?
- Blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2022to 19 Dec 2022
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks
Who cannot join
- pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Marshall University School of Medicine
Huntington, West Virginia, 25701
Jesse Cottrell, MD, 304-691-1460, cottrellje@marshall.edu
About this study
Official title: The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
This study will examine the effect if blood on the the protein to creatine (PC) ratio in pregnant patients by adding blood to urine samples.
Read the detailed description
The Purpose of the Research:
The purpose of this study is to examine the effect of blood on the protein to creatine (PC) ratio in pregnant patients.
The Scientific or Scholarly Rationale:
The PC ratio is used to diagnosis proteinuria in pregnancy. It is thought that blood in the urine will cause the PC ratio to be elevated but there are no current studies to prove this hypothesis.
The Procedures to be Performed:
Upon presentation to the Labor and Delivery Triage or the Antepartum Unit, patients will be enrolled in the study. Urine collection that is not needed for medical workup will be collected and saved, and an extra 8 mLs of blood will be drawn during routine lab collection by phlebotomy team. Additional lab costs will be covered by Marshall Obstetrics \& Gynecology.
Lab protocol: Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio:
- UA and PC ratio on original sample
- UA and PC ratio with 1 mL of whole blood added
- UA and PC ratio with 2 mL of whole blood added
- UA and PC ratio with 5 mL of whole blood added
Subjects medical records will be reviewed for past obstetrical history after consent to be in the study.
The Risks and Potential Benefits of the Research:
Risks: 8 mLs of additional maternal blood will be drawn for study purposes. Possible risks could include pain, bleeding, fainting, bruising, infection, or hematoma (blood clot under the skin) at the injection site. Please note that routine blood would be drawn regardless of study enrollment.
Benefits: Our hypothesis is that the PC ratio will be elevated by contamination with blood. It is unknown if this hypothesis is correct.
Complete Inclusion/Exclusion Criteria (may be submitted separately if extensive):
Inclusion criteria includes patients presenting to Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks.
Exclusion criteria includes pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine).
- Conditions
- Proteinuria in Pregnancy
- Being tested
- Blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
An additional 8 mL of blood will be drawn during routine lab collection
| Study group | Role | What they receive |
|---|---|---|
| UA and PC ratio on original sample | No intervention | Original urine sample |
| UA and PC ratio with 1 mL of whole blood added | Active comparator | 1 mL of whole blood added to 20 mLs of urine Receives: Other: Blood draw |
| UA and PC ratio with 2 mL of whole blood added | Active comparator | 2 mL of whole blood added to 20 mLs of urine Receives: Other: Blood draw |
| UA and PC ratio with 5 mL of whole blood added | Active comparator | 5 mL of whole blood added to 20 mLs of urine Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the PC ratio after whole blood has been serially added
The PC ratio is used to diagnose proteinuria in pregnancy. Our goal is to determine if blood causes the PC ratio to be elevated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start19 Jun 2022
- Primary completion19 Dec 2022 (estimated)
- Study completion19 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proteinuria in 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio: 1. UA and PC ratio on original sample 2. UA and PC ratio with 1 mL of whole blood added 3. UA and PC ratio with 2 mL of whole blood added 4. UA and PC ratio with 5 mL of whole blood added
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Principal investigator, Jesse Cottrell, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434845
- Sponsor's protocol ID
- 1912480
- Status last verified
- Sep 2022
- First submitted
- 21 Jun 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be accessed by the IRB approved research team
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
- ClinicalTrials.gov ID
- NCT05434845
- Acronym / sponsor ID
- 1912480
- Conditions
- Proteinuria in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 19 Dec 2022 (estimated)
- Study completion
- 19 Dec 2022 (estimated)
- First posted
- 28 Jun 2022 (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 study will examine the effect if blood on the the protein to creatine (PC) ratio in pregnant patients by adding blood to urine samples.
Detailed description
The Purpose of the Research:
The purpose of this study is to examine the effect of blood on the protein to creatine (PC) ratio in pregnant patients.
The Scientific or Scholarly Rationale:
The PC ratio is used to diagnosis proteinuria in pregnancy. It is thought that blood in the urine will cause the PC ratio to be elevated but there are no current studies to prove this hypothesis.
The Procedures to be Performed:
Upon presentation to the Labor and Delivery Triage or the Antepartum Unit, patients will be enrolled in the study. Urine collection that is not needed for medical workup will be collected and saved, and an extra 8 mLs of blood will be drawn during routine lab collection by phlebotomy team. Additional lab costs will be covered by Marshall Obstetrics \& Gynecology.
Lab protocol: Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio:
- UA and PC ratio on original sample
- UA and PC ratio with 1 mL of whole blood added
- UA and PC ratio with 2 mL of whole blood added
- UA and PC ratio with 5 mL of whole blood added
Subjects medical records will be reviewed for past obstetrical history after consent to be in the study.
The Risks and Potential Benefits of the Research:
Risks: 8 mLs of additional maternal blood will be drawn for study purposes. Possible risks could include pain, bleeding, fainting, bruising, infection, or hematoma (blood clot under the skin) at the injection site. Please note that routine blood would be drawn regardless of study enrollment.
Benefits: Our hypothesis is that the PC ratio will be elevated by contamination with blood. It is unknown if this hypothesis is correct.
Complete Inclusion/Exclusion Criteria (may be submitted separately if extensive):
Inclusion criteria includes patients presenting to Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks.
Exclusion criteria includes pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio: 1. UA and PC ratio on original sample 2. UA and PC ratio with 1 mL of whole blood added 3. UA and PC ratio with 2 mL of whole blood added 4. UA and PC ratio with 5 mL of whole blood added
| Arm | Type | Receives |
|---|---|---|
| UA and PC ratio on original sample | No intervention | –Original urine sample |
| UA and PC ratio with 1 mL of whole blood added | Active comparator | Other: Blood draw1 mL of whole blood added to 20 mLs of urine |
| UA and PC ratio with 2 mL of whole blood added | Active comparator | Other: Blood draw2 mL of whole blood added to 20 mLs of urine |
| UA and PC ratio with 5 mL of whole blood added | Active comparator | Other: Blood draw5 mL of whole blood added to 20 mLs of urine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks
Key exclusion criteria (1 listed)
- pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
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 |
|---|---|---|
| Blood drawAn additional 8 mL of blood will be drawn during routine lab collection | Other | UA and PC ratio with 1 mL of whole blood added, UA and PC ratio with 2 mL of whole blood added, UA and PC ratio with 5 mL of whole blood added |
Primary outcome
To measure the PC ratio after whole blood has been serially added
Time frame: 6 months
The PC ratio is used to diagnose proteinuria in pregnancy. Our goal is to determine if blood causes the PC ratio to be elevated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No. IPD will only be accessed by the IRB approved research team
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw in people with Proteinuria in Pregnancy, run by Marshall University at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesse Cottrell, MD (304-691-1400, cottrellj@marshall.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the PC ratio after whole blood has been serially added (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2022.