Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000455662
Ethics application status
Approved
Date submitted
11/04/2014
Date registered
1/05/2014
Date last updated
16/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Urinary neutrophil gelatinase-associated lipocalin
(NGAL) excretion and Renal Functions in Mild Maternal Hydronephrosis
Scientific title
Evaluation of the Outcomes of Renal functions and Urinary neutrophil gelatinase-associated lipocalin (NGAL) excretion in Mild Maternal Hydronephrosis and normal pregnancies
Secondary ID [1] 284232 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Maternal Hydronephrosis in Pregnancy 291345 0
Condition category
Condition code
Renal and Urogenital 291708 291708 0 0
Kidney disease
Reproductive Health and Childbirth 292066 292066 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Weeks
Description of intervention(s) / exposure
A total number of approximately 100 pregnant cases will be included in this prospective study. Subjects will be divided into 2 arms according to their urinary ultrasonographic findings between 24-36th week of their pregnancies. Pelvic-calyceal complex in millimeters from leading edge to leading edge, in two dimensions less than 5mm will be included in control arm, whereas dimensions between 5-15mm will be included in study arm as mild hydronephrosis cases. Urinary neutrophil gelatinase-associated lipocalin (NGAL) excretion and other renal functions will be determined on the day of ultrasonography.
Intervention code [1] 288938 0
Not applicable
Comparator / control treatment
Control group will be consisted of pregnants without identified hydronephrosis with ultrasonography.
Control group
Active

Outcomes
Primary outcome [1] 291648 0
Urinary neutrophil gelatinase-associated lipocalin (NGAL) levels in terms of microgram/L per patient along with the review of patient medical records
Timepoint [1] 291648 0
on the day of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [1] 307223 0
blood urea nitrogen (mg/dL) levels per patient along with the review of patient medical records
Timepoint [1] 307223 0
on the day of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [2] 307224 0
serum creatinine (mg/dL) levels per patient along with the review of patient medical records
Timepoint [2] 307224 0
on the day of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [3] 307225 0
serum uric acid (mg/dL) levels per patient along with the review of patient medical records
Timepoint [3] 307225 0
on the day of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [4] 307226 0
urinary albumin (mg/dL) levels per patient along with the review of patient medical records
Timepoint [4] 307226 0
on the day of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [5] 307227 0
urinary creatinine (mg/dL) levels per patient along with the review of patient medical records
Timepoint [5] 307227 0
on the day of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [6] 307228 0
total protein excretion (mg) of urine analysis in 24 hour period per patient along with the review of patient medical records
Timepoint [6] 307228 0
24 hours after completion of ultrasonography (between 24-36th week of their pregnancy)
Secondary outcome [7] 307794 0
glomerular filtration rate (GFR) calculation with Cystatin-C per patient along with the review of patient medical records
Timepoint [7] 307794 0
on the day of ultrasonography (between 24-36th week of their pregnancy)

Eligibility
Key inclusion criteria
singleton pregnancies between 24-36 weeks of gestation without identifiable maternal and fetal disorders other than maternal hydronephrosis.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Active urinary tract infection
-urolithiasis
-known genitourinary anomalies
-gestational or nongestational diabetes mellitus
-preeclampsia
-chronic hypertension
-chronic kidney or liver diseases
-chronic vascular or connective tissue diseases
The well-being of the fetus and the pregnancy was
established with a biophysical profile scoring. Pregnancies
with a jeopardized fetus, Bishop score over four, or active
labor were excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
POWER ANALYSIS:
Group sample sizes of 43 and 43 achieve 90% power to detect a difference of -50.0 between the
null hypothesis that both group means are 50.0 and the alternative hypothesis that the mean of
group 2 is 100.0 with known group standard deviations of 50.0 and 100.0 and with a significance
level (alpha) of 0.05000 using a one-sided two-sample t-test.
In conclusion, 43 patiens will be allocated for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2014
Actual
19/05/2014
Date of last participant enrolment
Anticipated
26/02/2015
Actual
2/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 5882 0
Turkey
State/province [1] 5882 0

Funding & Sponsors
Funding source category [1] 288861 0
Self funded/Unfunded
Name [1] 288861 0
Emre Goksan Pabuccu, M.D.
Country [1] 288861 0
Turkey
Primary sponsor type
Individual
Name
Emre Goksan Pabuccu
Address
Ufuk Universitesi Tip Fakultesi Dr. Ridvan Ege Hastanesi Kadin Hastaliklari ve Dogum Anabilim Dali Mevlana Bulvari Konya Yolu No:86-88 (06520) BALGAT ANKARA
Country
Turkey
Secondary sponsor category [1] 287557 0
Individual
Name [1] 287557 0
Gamze Sinem Caglar, Assoc.Prof., M.D.
Address [1] 287557 0
Ufuk Universitesi Tip Fakultesi Dr. Ridvan Ege Hastanesi Kadin Hastaliklari ve Dogum Anabilim Dali Mevlana Bulvari Konya Yolu No:86-88 (06520) BALGAT ANKARA
Country [1] 287557 0
Turkey

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 kDa protein of the lipocalin superfamily. NGAL was identified in neutrophils and is expressed in many tissues,
including adipocytes, bone marrow, uterus, stomach, colon, lung, liver, and kidney. This is especially seen in response to renal tubular injury, and NGAL appears so rapidly in the urine and serum that it is useful as an early biomarker of renal failure.
Objective of the study is to assess the renal functions and urinary NGAL levels in pregnants with or without mild maternal hydronephrosis. Approximately 100 subjects will be included in this study. Cases with mild hydronephrosis will be included as study group and remaining normal subjects will be included as control group. Urinary NGAL levels and other renal functions will be compared between groups using statistical methods following completion of all medical records.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46822 0
Dr Emre Goksan Pabuccu
Address 46822 0
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari N0:86, Konya Yolu uzeri
06520
Ankara
Country 46822 0
Turkey
Phone 46822 0
+90 532 414 7844
Fax 46822 0
Email 46822 0
[email protected]
Contact person for public queries
Name 46823 0
Dr Emre Goksan Pabuccu
Address 46823 0
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari N0:86, Konya yolu uzeri
06520
Ankara
Country 46823 0
Turkey
Phone 46823 0
+90 532 414 7844
Fax 46823 0
Email 46823 0
[email protected]
Contact person for scientific queries
Name 46824 0
Dr Emre Goksan Pabuccu
Address 46824 0
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari N0:86, Konya yolu uzeri
06520
Ankara
Country 46824 0
Turkey
Phone 46824 0
+90 532 414 7844
Fax 46824 0
Email 46824 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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