Pregnancy ComplicationsNCT03661749
Urinary Protein to Creatinine Ratio in Term Pregnant Women
A study testing clean catch in people with Pregnancy Complications, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- clean catch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2018to Nov 2019
- 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 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women of 37 weeks gestation or greater
Who cannot join
- Urinary tract infections
- Hypertension
- Pre-eclampsia
- Renal dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's University Hospital
Bethlehem, Pennsylvania, 18015
About this study
Official title: Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine
This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.
Read the detailed description
Clean catch urine should be used due to possible vaginal secretion contamination with falsely elevated U Pr/Cr ratio. However, no supporting reference was found in the article and no control group with random urine collection for comparison to clean catch specimen U Pr/Cr was included in their study. The original studies that validated spot Pr/Cr urine as a predictor of 24 -hour total urine protein used random non-clean catch random urines . They had an r value of .93-.99 in estimating total protein excreted in 24 hours. At our institution we use Siemens-base test to determine U Pr/Cr. In the product insert the company states that no special patient preparation is necessary.
Thus, this study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.
- Conditions
- Pregnancy Complications
- Being tested
- clean catch
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clean catchOther
clean catch technique applied to collect urine for PR/CR ratio
| Study group | Role | What they receive |
|---|---|---|
| Clean catch | Experimental | women in this group will collect urine for PR/CR using a clean catch technique Receives: Other: clean catch |
| Non-clean catch | Placebo comparator | women in this group will not employ clean catch technique Receives: Other: clean catch |
What is being measured
The primary outcome is the main question the study is designed to answer.
elevated PR/CR ratio using clean catch technique
this will be the proportion of patients with PR/CR ratio greater than or equal to 0.3 in urine using a clean catch method.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Report the incident of PR/CR ratio greater than 0.3
overall incident of elevated PR/CR ratio in healthy term pregnant women
Measured: through study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Anasti, MD, St. Luke's Hospital, Pennsylvania
- Investigators
- James N Anasti, MD, Principal investigator, St Luke's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661749
- Sponsor's protocol ID
- SLIR 2018-22
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine
- ClinicalTrials.gov ID
- NCT03661749
- Acronym / sponsor ID
- SLIR 2018-22
- Conditions
- Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Sep 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.
This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.
Detailed description
Clean catch urine should be used due to possible vaginal secretion contamination with falsely elevated U Pr/Cr ratio. However, no supporting reference was found in the article and no control group with random urine collection for comparison to clean catch specimen U Pr/Cr was included in their study. The original studies that validated spot Pr/Cr urine as a predictor of 24 -hour total urine protein used random non-clean catch random urines . They had an r value of .93-.99 in estimating total protein excreted in 24 hours. At our institution we use Siemens-base test to determine U Pr/Cr. In the product insert the company states that no special patient preparation is necessary.
Thus, this study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
| Arm | Type | Receives |
|---|---|---|
| Clean catch | Experimental | Other: clean catchwomen in this group will collect urine for PR/CR using a clean catch technique |
| Non-clean catch | Placebo comparator | Other: clean catchwomen in this group will not employ clean catch technique |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- women of 37 weeks gestation or greater
Key exclusion criteria (4 listed)
- Urinary tract infections
- Hypertension
- Pre-eclampsia
- Renal dysfunction
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 |
|---|---|---|
| clean catchclean catch technique applied to collect urine for PR/CR ratio | Other | Clean catch, Non-clean catch |
Primary outcome
elevated PR/CR ratio using clean catch technique
Time frame: through study completion, an average of 1 year
this will be the proportion of patients with PR/CR ratio greater than or equal to 0.3 in urine using a clean catch method.
1 secondary outcome
Report the incident of PR/CR ratio greater than 0.3
Time frame: through study completion, average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- 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.
James N Anasti, MD principal investigator
St Luke's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clean catch in people with Pregnancy Complications, run by St. Luke's Hospital, Pennsylvania 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 4 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 7 Sep 2018. 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. Some participants in this study may receive a placebo. 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 James N Anasti, MD (484-526-8878, anastij@slhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elevated PR/CR ratio using clean catch technique (time frame: through study completion, an average of 1 year). 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 7 Sep 2018.