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Trial registered on ANZCTR


Registration number
ACTRN12618000497202
Ethics application status
Approved
Date submitted
26/12/2017
Date registered
6/04/2018
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of the calcium-creatinine ratio in spot urine sample in prediction of preeclampsia
Scientific title
Accuracy of the calcium-creatinine ratio in spot urine sample in prediction of preeclampsia
Secondary ID [1] 294220 0
-
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 305934 0
Pregnancy 306882 0
Condition category
Condition code
Reproductive Health and Childbirth 305129 305129 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 306398 306398 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As part of the routine follow-up in the ante-natal clinics, the urine sample taken from the pregnant women for urine albumin assessment at 12 weeks` and 30 weeks` gestation, and will be used for the assessment of the calcium-creatinine ratio after informed consent.
Intervention code [1] 299909 0
Early Detection / Screening
Comparator / control treatment
The study will include women between 20-40 years old, attending the ante-natal clinic of Ahmadi hospital for ante-natal care during the period from May 2018 till May 2019 after informed consent, and approval of the Obstetrics department .
A complete obstetrical history, clinical examination, the necessary investigations will be done to exclude other conditions affecting urinary calcium/creatinine ratio.
As part of the routine follow-up in the ante-natal clinics, the urine sample taken from the pregnant women for urine albumin assessment, will be used for the assessment of the calcium-creatinine ratio after informed consent. Follow–up of the studied women till delivery; women who will develop preeclampsia will constitute the study group, and other normotensive women without preeclampsia will constitute the controls.
Control group
Active

Outcomes
Primary outcome [1] 304284 0
Primary outcome measures; the accuracy of calcium-creatinine ratio (CCR) in spot urine sample in prediction of preeclampsia.

Timepoint [1] 304284 0
The calcium-creatinine ratio (CCR) in spot urine sample will detected for all women attending the antenatal clinic and agreed to participate in the study within 5 minutes, and will be recorded, the participants will followed up till delivery.
Whole women (study and controls) included in the study from May 2018 till May 2019 will be followed-up till delivery.
At time of admission to the hospital, and/or delivery; the participants [study and controls], will classified to normotensive [controls] women, and pre-eclampsia [study] women.
The calcium-creatinine ratio (CCR) in spot urine sample taken during the antenatal care will compared in normotensive and pre-eclampsia women at delivery to detect the accuracy of calcium-creatinine ratio (CCR) in spot urine sample in prediction of preeclampsia.
Secondary outcome [1] 343080 0
Previous preeclampsia as possible risks of preeclampsia.
Timepoint [1] 343080 0
Taking detailed Obstetrics history at the antenatal clinic during the antenatal follow up at approximately 30 weeks gestation.
Secondary outcome [2] 343083 0
Obesity as possible risk of preeclampsia.
Timepoint [2] 343083 0
Measuring the body mass index [BMI] at antenatal clinic at the time of inclusion in the study.
Secondary outcome [3] 343084 0
Hyperlipidaemia as possible risk of preeclampsia.
Using the serum assay of the lipid profile (Total cholesterol, Triglycerides. High density and low density lipoproteins).
Timepoint [3] 343084 0
Laboratory investigations during the antenatal follow up using the serum assay of the lipid profile (Total cholesterol, Triglycerides. High density and low density lipoproteins) during the antenatal follow up at approximately 30 weeks gestation. .
Secondary outcome [4] 343089 0
Preterm labor [PTL] as possible complications of preeclampsia.
Timepoint [4] 343089 0
Using the birthing medical records.
Secondary outcome [5] 343874 0
Intrauterine growth retardation [IUGR] as possible complications of preeclampsia.
Timepoint [5] 343874 0
Using the birthing medical records.

Eligibility
Key inclusion criteria
The study will include women between 20-40 years old, attending the ante-natal clinic of Ahmadi hospital for ante-natal care during the period from May 2018 till May 2019 after informed consent, and approval of the Obstetrics department .
Women <20 years, >40 years age, refused to participate in the study and/or refused to give consent will excluded from the study.
A complete obstetrical history, clinical examination, the necessary investigations will be done to exclude other conditions affecting urinary calcium/creatinine ratio.
As part of the routine follow-up in the ante-natal clinics, the urine sample taken from the pregnant women for urine albumin assessment, will be used for the assessment of the calcium-creatinine ratio after informed consent. Follow–up of the studied women till delivery; women who will develop preeclampsia will constitute the study group, and other normotensive women without preeclampsia will constitute the controls.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women <20 years, >40 years age, refused to participate in the study and/or refused to give consent will excluded from the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The required sample size was calculated using G Power software version 3.17 for sample size calculation (Heinrich Heine Universität; Düsseldorf; Germany), setting a -error probability at 0.05, power (1- ß error probability) at 0.95%, and effective sample size (w) at 0.3. Collected data will statistically analyzed using Statistical Package for Social Sciences (SPSS); computer software version 20 (Chicago, IL, USA). Chi-square test (x2) for qualitative variables, student (t) test for comparison numerical variables to detect the accuracy of the CCR in spot urine sample in prediction of preeclampsia. The Odds ratio, and the relative risk analysis for detection of the possible risks factors for preeclampsia (nulliparity, previous preeclampsia, obesity, hyperlipidemia, twin, and molar pregnancies), and complications associated with preeclampsia (PTL and/or IUGR).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9453 0
Kuwait
State/province [1] 9453 0
Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors
Funding source category [1] 298265 0
Hospital
Name [1] 298265 0
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
Address [1] 298265 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 298265 0
Kuwait
Primary sponsor type
Hospital
Name
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
Address
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country
Kuwait
Secondary sponsor category [1] 297379 0
Individual
Name [1] 297379 0
Ibrahim A. Abdelazim
Address [1] 297379 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 297379 0
Kuwait
Secondary sponsor category [2] 297380 0
Individual
Name [2] 297380 0
Mohannad AbuFaza
Address [2] 297380 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [2] 297380 0
Kuwait
Secondary sponsor category [3] 297381 0
Individual
Name [3] 297381 0
Waheeb Naser
Address [3] 297381 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [3] 297381 0
Kuwait

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299267 0
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
Ethics committee address [1] 299267 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 299267 0
Kuwait
Date submitted for ethics approval [1] 299267 0
18/12/2017
Approval date [1] 299267 0
25/12/2017
Ethics approval number [1] 299267 0

Summary
Brief summary
Background: Preeclampsia is a pregnancy complication, associated with fetal, and maternal morbidity. There is no established test that fulfills all criteria as a good predictor of preeclmpsia. Objectives: This prospective comparative study designed to evaluate the accuracy of calcium-creatinine ratio (CCR) in spot urine sample in prediction of preeclampsia. Study Design: Prospective comparative study.
Patient and methods: The study will include women between 20-40 years old, attending the ante-natal clinic of Ahmadi hospital for ante-natal care during the period from May 2018 till May 2019 after informed consent, and approval of the Obstetrics department .
After complete obstetrical history, clinical examination, the necessary investigations will be done to exclude other conditions affecting urinary calcium/creatinine ratio.
As part of the routine follow-up in the ante-natal clinics, the urine sample taken from the pregnant women for urine albumin assessment, will be used for the assessment of the CCR after informed consent.
Follow–up of the studied women till delivery; women who will develop preeclampsia will constitute the study group, and other normotensive women without preeclampsia will constitute the controls.

Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2298 2298 0 0
Attachments [2] 2304 2304 0 0

Contacts
Principal investigator
Name 79846 0
Prof Ibrahim A. Abdelazim
Address 79846 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79846 0
Kuwait
Phone 79846 0
+965-66551300
Fax 79846 0
Email 79846 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 79847 0
Dr Mohannad AbuFaza
Address 79847 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79847 0
Kuwait
Phone 79847 0
+965-60096196
Fax 79847 0
Email 79847 0
Mabufaza@gmail.com
Contact person for scientific queries
Name 79848 0
Dr Ibrahim A. Abdelazim
Address 79848 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79848 0
Kuwait
Phone 79848 0
+965-66551300
Fax 79848 0
Email 79848 0
dr.ibrahimanwar@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
line-by line data collected from each participant.
When will data be available (start and end dates)?
Start date 1/6/2018
End date 31/5/2019
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
By what mechanism will data be made available?
Access subject to approvals by principal investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
Summary results
Not applicable