## Protocol Section
### Identification Module
**NCT ID:** NCT06413576

**Brief Title:** Homocysteine in Critically Ill Preeclampsia

**Official Title:** The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients

#### Organization Study ID Info
**ID:** FMASU R09/2024
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-19

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-19

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-06
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pre-Eclampsia

- Critical Illness

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Normotensive age- matched pregnant controls

**Intervention Names:**

- Diagnostic Test: homocysteine measurement

**Label:** normal pregnancy

#### Arm Group 2

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

**Intervention Names:**

- Diagnostic Test: homocysteine measurement

**Label:** preeclampsia

#### Arm Group 3

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

**Intervention Names:**

- Diagnostic Test: homocysteine measurement

**Label:** critically ill preeclampsia

### Interventions

#### Intervention 1

**Arm Group Labels:**

- critically ill preeclampsia

- normal pregnancy

- preeclampsia

**Description:** measuring the serum level of homocysteine

**Name:** homocysteine measurement

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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 .

**Measure:** homocysteine level

**Time Frame:** within 24 hours postoperative(post delivery)

#### Secondary Outcomes

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

**Measure:** Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia

**Time Frame:** within 24 hours postoperative

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Gender Description:** pregnant females

**Healthy Volunteers:** True

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** pregnant females with pre-eclampsia and within 24 hours of delivery

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** w.z.selima@gmail.com

**Name:** wessam selima, MD

**Phone:** +201001958858

**Role:** CONTACT

**Contact 2:**

**Name:** Amera ahmed, MD

**Phone:** +201000358439

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** REC-FAMSU@med.asu.edu.eg

- **Name:** fathy tash, MD

- **Phone:** 2022685

- **Phone Ext:** 7539

- **Role:** CONTACT

***Contact 2:***

- **Name:** rania gamal, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Amera ahmed, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Rasha ahmed, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Ain shams University

**Status:** RECRUITING

**Zip:** 11591

**Location 2:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** anesth_office@med.asu.edu.eg

- **Name:** Anesthesia department

- **Phone:** 01009499962

- **Role:** CONTACT

***Contact 2:***

- **Email:** w.z.selima@med.asu.edu.eg

- **Phone Ext:** selima

- **Role:** CONTACT

***Contact 3:***

- **Name:** wessam selima, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Amera Ahmed, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Rania Gamal, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 6:***

- **Name:** Rasha Ahmed, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Ain shams university

**State:** القاهرة

**Status:** RECRUITING

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M7633

- Name: Eclampsia

- Relevance: HIGH

- As Found: Eclampsia

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: HIGH

- As Found: Pre-Eclampsia

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T2019

- Name: Eclampsia

- Relevance: HIGH

- As Found: Eclampsia

### Condition Browse Module - Meshes

- ID: D000011225

- Term: Pre-Eclampsia

- ID: D000004461

- Term: Eclampsia

- ID: D000016638

- Term: Critical Illness

### Misc Info Module

- Version Holder: 2024-05-31
