Pre-EclampsiaNCT06413576
Homocysteine in Critically Ill Preeclampsia
An observational study of Pre-Eclampsia and Critical Illness, run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Critical Illness
- What is being tested?
- homocysteine measurement
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 19 Jan 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant females with pre-eclampsia and within 24 hours of delivery
Who may be able to join
- 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 .
Who cannot join
- 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
Show all 10Show fewer
- Space occupying lesion in brain like tuberculoma or brain tumor
- Trauma to brain
- Hyperpyrexia
- On treatment with antifolate drugs such as methotrexate
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams University
Cairo, Cairo Governorate, 11591
Ain shams university
Cairo, Cairo Governorate
About this study
Official title: The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients
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.
Read the 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
- Pre-Eclampsia, Critical Illness
- Being tested
- homocysteine measurement
- Medical subject headings
- Pre-Eclampsia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homocysteine measurementDiagnostic test
measuring the serum level of homocysteine
| Study group | Role | What they receive |
|---|---|---|
| normal pregnancy | Normotensive age- matched pregnant controls Receives: Diagnostic Test: homocysteine measurement | |
| preeclampsia | pre-eclampsia patients who are managed in ward (not critical) Receives: Diagnostic Test: homocysteine measurement | |
| critically ill preeclampsia | pre-eclampsia patients who are admitted to intensive care unit due to severity or complications Receives: Diagnostic Test: homocysteine measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: within 24 hours postoperative(post delivery)
Secondary outcomes (1)
Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia
the co relation between levels of homocysteine and degree of severity of preeclampsia using spearman rank correlation co efficient
Measured: within 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start19 Jan 2024
- Primary completion10 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413576
- Sponsor's protocol ID
- FMASU R09/2024
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26985406Thakur 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.
PubMed 36968916Chaudhry 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.
PubMed 32188521Aubard 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.
PubMed 11074137
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients
- ClinicalTrials.gov ID
- NCT06413576
- Acronym / sponsor ID
- FMASU R09/2024
- Conditions
- Pre-Eclampsia, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal pregnancy | – | Diagnostic Test: homocysteine measurementNormotensive age- matched pregnant controls |
| preeclampsia | – | Diagnostic Test: homocysteine measurementpre-eclampsia patients who are managed in ward (not critical) |
| critically ill preeclampsia | – | Diagnostic Test: homocysteine measurementpre-eclampsia patients who are admitted to intensive care unit due to severity or complications |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant females with pre-eclampsia and within 24 hours of delivery
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| homocysteine measurementmeasuring the serum level of homocysteine | Diagnostic test | critically ill preeclampsia, normal pregnancy, preeclampsia |
Primary outcome
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 .
1 secondary outcome
Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia
Time frame: within 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 26985406Salam 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.
- Background: PubMed 36968916Thakur 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.
- Background: PubMed 32188521Chaudhry 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.
- Background: PubMed 11074137Aubard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia and Critical Illness, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
homocysteine level (time frame: within 24 hours postoperative(post delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06413576, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.