NCT03661749

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

August 31, 2018

Last Update Submit

September 6, 2018

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Report the incident of PR/CR ratio greater than 0.3

    through study completion, average of 1 year

Study Arms (2)

Clean catch

EXPERIMENTAL

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

Other: clean catch

Non-clean catch

PLACEBO COMPARATOR

women in this group will not employ clean catch technique

Other: clean catch

Interventions

clean catchOTHER

clean catch technique applied to collect urine for PR/CR ratio

Clean catchNon-clean catch

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females 37 weeks gestation or greater
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women of 37 weeks gestation or greater

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • James N Anasti, MD

    St Luke's University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James N Anasti, MD

CONTACT

484-526-8878anastij@slhn.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of OB/GYN

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 7, 2018

Study Start

September 1, 2018

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

US(1)