Homocysteine in Critically Ill Preeclampsia

NCT06413576 | Completed DMC

• 1 other identifier: FMASU R09/2024
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Pre-Eclampsia; Critical Illness

Outcome Measures

Primary Outcomes (1)

• homocysteine level

  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 .

  within 24 hours postoperative(post delivery)

Secondary Outcomes (1)

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

  within 24 hours postoperative

Study Arms (3)

normal pregnancy

Normotensive age- matched pregnant controls

Diagnostic Test: homocysteine measurement

preeclampsia

pre-eclampsia patients who are managed in ward (not critical)

Diagnostic Test: homocysteine measurement

critically ill preeclampsia

pre-eclampsia patients who are admitted to intensive care unit due to severity or complications

Diagnostic Test: homocysteine measurement

Interventions

homocysteine measurement DIAGNOSTIC_TEST

measuring the serum level of homocysteine

critically ill preeclampsia; normal pregnancy; preeclampsia

Eligibility Criteria

• Gender Eligibility Details: pregnant females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pregnant females with pre-eclampsia and within 24 hours of delivery

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain shams University

Cairo, Cairo Governorate, 11591, Egypt

Location

Ain shams university

Cairo, Cairo Governorate, Egypt

Location

Related Publications (4)

• Salam RA, Das JK, Ali A, Bhaumik S, Lassi ZS. Diagnosis and management of preeclampsia in community settings in low and middle-income countries. J Family Med Prim Care. 2015 Oct-Dec;4(4):501-6. doi: 10.4103/2249-4863.174265.

  PMID: 26985406 BACKGROUND

• Thakur P, Bhalerao A. High Homocysteine Levels During Pregnancy and Its Association With Placenta-Mediated Complications: A Scoping Review. Cureus. 2023 Feb 20;15(2):e35244. doi: 10.7759/cureus.35244. eCollection 2023 Feb.

  PMID: 36968916 BACKGROUND

• Chaudhry SH, Taljaard M, MacFarlane AJ, Gaudet LM, Smith GN, Rodger M, Rennicks White R, Walker MC, Wen SW. The determinants of maternal homocysteine in pregnancy: findings from the Ottawa and Kingston Birth Cohort. Public Health Nutr. 2020 Dec;23(17):3170-3180. doi: 10.1017/S1368980019004002. Epub 2020 Mar 19.

  PMID: 32188521 BACKGROUND

• Aubard Y, Darodes N, Cantaloube M. Hyperhomocysteinemia and pregnancy--review of our present understanding and therapeutic implications. Eur J Obstet Gynecol Reprod Biol. 2000 Dec;93(2):157-65. doi: 10.1016/s0301-2115(00)00282-7.

  PMID: 11074137 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Critical Illness

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: May 14, 2024
• Study Start: January 19, 2024
• Primary Completion: November 10, 2024
• Study Completion: January 26, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

EG (2)