Accuracy of the calcium-creatinine ratio in spot urine sample in prediction of preeclampsia

• Register: ANZCTR
• Last refreshed on: 14 November 2022
• Main ID: ACTRN12618000497202
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
• 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
• Date of first enrolment: 01/06/2018
• Target sample size: 250
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000497202.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Kuwait

Contacts

• Name: Dr Ibrahim A. Abdelazim

• Name: Dr Mohannad AbuFaza

Key inclusion & exclusion criteria

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.

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.

Age minimum: 20 Years
Age maximum: 40 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Cardiovascular - Hypertension

Preeclampsia;Pregnancy ;
Preeclampsia
Pregnancy

Intervention(s)

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.

Primary Outcome(s)

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

[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(s)

Hyperlipidaemia as possible risk of preeclampsia.
Using the serum assay of the lipid profile (Total cholesterol, Triglycerides. High density and low density lipoproteins). [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. .]

Intrauterine growth retardation [IUGR] as possible complications of preeclampsia.[Using the birthing medical records.]

Previous preeclampsia as possible risks of preeclampsia.[Taking detailed Obstetrics history at the antenatal clinic during the antenatal follow up at approximately 30 weeks gestation. ]

Preterm labor [PTL] as possible complications of preeclampsia.[Using the birthing medical records.]

Obesity as possible risk of preeclampsia. [Measuring the body mass index [BMI] at antenatal clinic at the time of inclusion in the study.]

Source(s) of Monetary Support

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Secondary Sponsor(s)

Souad Al-Ajmi

Mohannad AbuFaza

Ibrahim A. Abdelazim

Ethics review

Status: Approved
Approval date: 25/12/2017
Contact:

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Results

• Results available: Yes
• Date Posted: 22/10/2021
• Date Completed: 20/09/2021