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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

8/11/2022

Date data sharing statement initially provided

14/01/2019

Date results provided

22/10/2021

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]

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preeclampsia

Pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Cardiovascular

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]

Early Detection / Screening

Comparator / control treatment

The study will include women between 20-40 years old, attending the ante-natal clinic of 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]

Primary outcome measures; the accuracy of calcium-creatinine ratio (CCR) in spot urine sample in prediction of preeclampsia.

Timepoint [1]

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]

Previous preeclampsia as possible risks of preeclampsia.

Timepoint [1]

Taking detailed Obstetrics history at the antenatal clinic during the antenatal follow up at approximately 30 weeks gestation.

Secondary outcome [2]

Obesity as possible risk of preeclampsia.

Timepoint [2]

Measuring the body mass index [BMI] at antenatal clinic at the time of inclusion in the study.

Secondary outcome [3]

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]

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]

Preterm labor [PTL] as possible complications of preeclampsia.

Timepoint [4]

Using the birthing medical records.

Secondary outcome [5]

Intrauterine growth retardation [IUGR] as possible complications of preeclampsia.

Timepoint [5]

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 for ante-natal care during the period from May 2018 till May 2020 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

Sex

Females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/05/2018

Actual

1/06/2018

Date of last participant enrolment

Anticipated

2/09/2019

Actual

30/08/2021

Date of last data collection

Anticipated

2/10/2019

Actual

20/09/2021

Sample size

Target

250

Accrual to date

Final

246

Recruitment outside Australia

Country [1]

Kuwait

State/province [1]

Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Address [1]

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1]

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]

Individual

Name [1]

Ibrahim A. Abdelazim

Address [1]

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1]

Kuwait

Secondary sponsor category [2]

Individual

Name [2]

Mohannad AbuFaza

Address [2]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [2]

Kuwait

Secondary sponsor category [3]

Individual

Name [3]

Souad Al-Ajmi

Address [3]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [3]

Kuwait

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Ethics committee address [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Ethics committee country [1]

Kuwait

Date submitted for ethics approval [1]

18/12/2017

Approval date [1]

25/12/2017

Ethics approval number [1]

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

Contacts

Principal investigator

Name

Prof Ibrahim A. Abdelazim

Address

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

[email protected]

Contact person for public queries

Name

Mohannad AbuFaza

Address

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-60096196

Fax

[email protected]

Contact person for scientific queries

Name

Ibrahim A. Abdelazim

Address

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Its the patient`s right to share her identity or not

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13711	Study protocol					374197-(Uploaded-15-04-2020-20-48-01)-Study-related document.docx
13712	Ethical approval					374197-(Uploaded-06-02-2021-01-18-45)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The accuracy of the calcium-creatinine ratio in a spot urine sample for predicting preeclampsia.	2022	https://dx.doi.org/10.5114/pm.2022.119755

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically