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NCT Number: NCT06413576

Homocysteine in Critically Ill Preeclampsia

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Ain shams University, Cairo, Cairo Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

homocysteine measurement

Diagnostic Test

measuring the serum level of homocysteine

Primary outcomes

  1. homocysteine level

    Time frame: within 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 outcomes

  1. Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia

    Time frame: within 24 hours postoperative

    the co relation between levels of homocysteine and degree of severity of preeclampsia using spearman rank correlation co efficient

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 14, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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