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Homocysteine in Critically Ill Preeclampsia

The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06413576
Enrollment
70
Registered
2024-05-14
Start date
2024-01-19
Completion date
2025-06-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Pre-Eclampsia

Brief summary

Preeclampsia is a disorder characterized by the new onset of hypertension and proteinuria typically presenting after 20 weeks of gestation. Elevated circulating homocysteine is a risk factor for endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Our study is to investigate the association between elevated blood homocysteine levels and complications in pregnant women in order to conclude the clinical utility of homocysteine as a marker of severity in the cases of pre-eclampsia.

Detailed description

Hypertensive disorders of pregnancy are an important cause of morbidity and mortality among mothers and infants. Preeclampsia is a pregnancy-related hypertensive disorder occurring usually after 20 weeks of gestation. It is associated with fetal growth restriction, low birth weight, preterm birth, respiratory distress syndrome, and admission to a neonatal intensive care unit. According to a systemic review and meta-analysis published in 2013, preeclampsia has a noticeable relationship with an increased risk of developing hypertension, ischemic heart disease, and cerebrovascular accident in later life. There is already abundant evidence indicating that elevated serum homocysteine levels may be related to the risk of coronary, cerebral, and peripheral arterial diseases. Elevated circulating homocysteine is a risk factor of endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Normally, homocysteine levels decline throughout pregnancy and since the vascular alterations brought on by homocysteine are comparable to those brought on by hypertensive disorders of pregnancy, it can be assumed that high levels of homocysteine are linked to the hypertensive disorder spectrum. Homocysteine has been shown to produce oxidative stress and endothelial dysfunction, endothelial cell injury and thrombus formation and thereby producing pre-eclampsia. Estimation of homocysteine may help to predict and prevent pre-eclampsia and eclampsia, thus reducing the undesired outcome of pregnancy. Among various studies, there is a lack of consistency in the reported results that support the link between maternal homocysteine concentrations assessed throughout each of the three trimesters of pregnancy and difficulties caused by the placenta. our study investigate the relation between the level of homocysteine and severity of preeclampsia.

Interventions

DIAGNOSTIC_TESThomocysteine measurement

measuring the serum level of homocysteine

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* All patients diagnosed by preeclampsia will be included in light of the following diagnostic criteria (blood pressure more than 140\\90 mm\\Hg on 2 occasions at least 4 hours apart after 20 weeks' gestation in a previously normotensive patient accompanied by Protein/creatinine ratio ≥0.3 .

Exclusion criteria

* Essential hypertension suggested by history or documentation of hypertension in pre pregnant state or hypertension before 20 weeks of gestation. * Cardiovascular or renal failure * Liver failure * Diabetes mellitus * Inflammatory or infective disorders * History or documentation of epilepsy in prepregnant state * Space occupying lesion in brain like tuberculoma or brain tumor * Trauma to brain * Hyperpyrexia * On treatment with antifolate drugs such as methotrexate

Design outcomes

Primary

MeasureTime frameDescription
homocysteine levelwithin 24 hours postoperative(post delivery)Quantitative measurement of the serum level of homocysteine. The measurement will be done using a commercially available sandwich enzyme linked immunosorbent assay (ELIZA) kit supplied by ( Bioassay technology laboratory) according to the manufacturer's instructions.nthe results will be expressed in ng/ml. Absorbance of standards and samples were measured at 450 nm using a microtiter plate ELISA reader .

Secondary

MeasureTime frameDescription
Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsiawithin 24 hours postoperativethe co relation between levels of homocysteine and degree of severity of preeclampsia using spearman rank correlation co efficient

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026