An interventional study of clean catch in Pregnancy Complications, sponsored by St. Luke's Hospital, Pennsylvania. Status unknown at 1 site in United States. Open to female participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by St. Luke's Hospital, Pennsylvania · Not applicable, Interventional, and Other
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.
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.
445 studies on the registry are indexed under Pregnancy Complications; 115 are open to participants now.
This study's planned enrollment of 240 is above the median of 147 across 224 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →St. Luke's Hospital, Pennsylvania is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
women in this group will collect urine for PR/CR using a clean catch technique
Other: clean catch
women in this group will not employ clean catch technique
Other: clean catch
clean catch technique applied to collect urine for PR/CR ratio
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.
Time frame: through study completion, an average of 1 year
Report the incident of PR/CR ratio greater than 0.3
overall incident of elevated PR/CR ratio in healthy term pregnant women
Time frame: through study completion, average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2018; primary completion for Aug 2019, 11 months later.
Of 133 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 11 months is below that.
Counting every sponsor, half of 133 studies reached it within 29 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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St. Luke's Hospital, Pennsylvania