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Homocysteine in Critically Ill Preeclampsia

A

Ain Shams University

Status

Completed

Conditions

Pre-Eclampsia
Critical Illness

Treatments

Diagnostic Test: homocysteine measurement

Study type

Observational

Funder types

Other

Identifiers

NCT06413576
FMASU R09/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

70 participants in 3 patient groups

normal pregnancy
Description:
Normotensive age- matched pregnant controls
Treatment:
Diagnostic Test: homocysteine measurement
preeclampsia
Description:
pre-eclampsia patients who are managed in ward (not critical)
Treatment:
Diagnostic Test: homocysteine measurement
critically ill preeclampsia
Description:
pre-eclampsia patients who are admitted to intensive care unit due to severity or complications
Treatment:
Diagnostic Test: homocysteine measurement

Trial contacts and locations

2

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Central trial contact

wessam selima, MD; Amera ahmed, MD

Data sourced from clinicaltrials.gov

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