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

Not Applicable

Completed

• Conditions: Preeclampsia; Pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Cardiovascular - Hypertension

• Registration Number: ACTRN12618000497202
• Lead Sponsor: Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Brief Summary

Research question: Accuracy of the calcium-creatinine ratio (CCR) in a spot urine sample for the prediction of preeclampsia (PE). Background: Currently, there is no reliable diagnostic test to predict preeclampsia. Participants: Two hundred and forty-six pregnant women, attending the ante-natal clinic after 20 weeks` gestation were included in this study. After exclusion of pre-existing chronic renal disease affecting calcium and/or creatinine excretion, spot urine samples were taken from participants to detect the calcium-creatinine ratio. Results: The calcium-creatinine ratio = 0.04 had 79.3% sensitivity, 96.3% specificity, 91.5% positive predictive value (PPV), 90.3% negative predictive value (NPV), and 90.7% overall accuracy in prediction of preeclampsia. Limitation: Women who refused to participate and/or give consent was the only limitation faced during this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-06
• Study Completion: 2021-09-20
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 246

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures; the accuracy of calcium-creatinine ratio (CCR) in spot urine sample in prediction of preeclampsia.<br><br>[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.<br>Whole women (study and controls) included in the study from May 2018 till May 2019 will be followed-up till delivery.<br>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. <br>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.<br>]

Secondary Outcome Measures

Name	Time	Method
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. ];Obesity as possible risk of preeclampsia. [Measuring the body mass index [BMI] at antenatal clinic at the time of inclusion in the study.];Hyperlipidaemia as possible risk of preeclampsia.<br>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. .];Preterm labor [PTL] as possible complications of preeclampsia.[Using the birthing medical records.];Intrauterine growth retardation [IUGR] as possible complications of preeclampsia.[Using the birthing medical records.]