Urinary Protein to Creatinine Ratio in Term Pregnant Women

St. Luke's Hospital, Pennsylvania

Status: Unknown

Conditions: Pregnancy Complications

Treatments: Other: clean catch

Study type: Interventional

Funder types: Other

Identifiers

NCT03661749

SLIR 2018-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women of 37 weeks gestation or greater

Exclusion criteria

• Urinary tract infections
• Hypertension
• Pre-eclampsia
• Renal dysfunction

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups, including a placebo group

Clean catch

Experimental group

Description:

women in this group will collect urine for PR/CR using a clean catch technique

Treatment:

Other: clean catch

Non-clean catch

Placebo Comparator group

Description:

women in this group will not employ clean catch technique

Treatment:

Other: clean catch