Preeclampsia (PE)PreeclampsiaNCT07119034
Assessment of Oxidative Stress Contents in Jordanian Pregnant Women With Preeclampsia
An observational study of Preeclampsia (PE) and Oxidative Stress, run by Future University in Egypt at 1 site in Jordan.
Trial summary
Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia (PE), Oxidative Stress
- What is being tested?
- Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
- How many people
- 90 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2022to 1 May 2023
- How long will I take part?
- 7 Months
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 45 with preeclampsia who completed the questionnaire, providing all necessary data
Who may be able to join
- Inclusion criteria specified pregnant women aged 20 to 40, diagnosed with preeclampsia based on blood pressure and proteinuria
Who cannot join
- applied to those with diabetes, liver or kidney diseases, cardiovascular diseases, or using specific supplements like vitamins A, C, and E.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Oxidative Stress Parameters in Jordanian Pregnant Women With Preeclampsia
Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women
Read the detailed description
Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women.
Methods: Ethical approval was obtained from Al-Ahliyya Amman University prior to starting the study. A total of 90 participants (45 preeclamptic pregnant women and 45 healthy pregnant women) were included in this study. Serum levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured by HUMAN200 auto analyzer (Germany) using a homogeneous enzymatic colorimetric assay. A kit from GenoChem world was used to measure the MDA levels via a colorimetric analysis technique Sandwich enzyme-linked immunosorbent assay (ELISA) was used to determine the serum levels of Trx and 4-HNE.
Results: The results revealed significantly elevated levels of MDA and 4-HNE in preeclamptic women compared to their healthy counterparts (P<0.001). Although Trx levels did not differ significantly (P=0.29), marked distinctions were observed in LDL-C, TC, HDL-C, systolic and diastolic blood pressure (P<0.001). Preeclamptic women exhibited substantially higher LDL, TC, and blood pressure, and lower HDL.
Conclusion: This study highlights the correlation between elevated oxidative stress markers and an elevated risk of preeclampsia in pregnant women, which may suggest the impact of these markers in the pathogenesis of preeclampsia. These findings underscore the need for a nuanced understanding of these markers to enhance prenatal care and facilitate targeted interventions
- Conditions
- Preeclampsia (PE), Oxidative Stress
- Being tested
- Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)Diagnostic test
Blood samples were collected from the antecubital vein and processed at the TrueLab medical laboratory. The whole blood was initially collected in plain tubes, and subsequently centrifuged to obtain serum samples. Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) Thioredoxin and 4-Hydroxynonenal quantification, malondialdehyde levels
| Study group | Role | What they receive |
|---|---|---|
| Control group | control group comprising 45 healthy pregnant women Receives: Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) | |
| Preeclampsia group | Preeclampsia group 45 women with preeclampsia Receives: Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxadative stress parameters
Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde
Measured: 7 months
Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde
Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Nov 2022
- Primary completion10 Nov 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Ahliyya Amman University
- Responsible party
- Principal investigator, Doaa Mohamed Salah ElDin Diab ELBohy, Al-Ahliyya Amman University
- Investigators
- Doaa El-Bohy, PhD, Principal investigator, Al-Ahliyya Amman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119034
- Sponsor's protocol ID
- Al-Ahliyya Amman University
- Other IDs
- Preeclsmpsia, Preeclampsia
- Acronym
- Preeclampsia
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Consent forms
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oxidative Stress Parameters in Jordanian Pregnant Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT07119034
- Acronym / sponsor ID
- Preeclampsia / Al-Ahliyya Amman University
- Conditions
- Preeclampsia (PE), Oxidative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Collaborators
- Al-Ahliyya Amman University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 12 Aug 2025 (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, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women
Detailed description
Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women.
Methods: Ethical approval was obtained from Al-Ahliyya Amman University prior to starting the study. A total of 90 participants (45 preeclamptic pregnant women and 45 healthy pregnant women) were included in this study. Serum levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured by HUMAN200 auto analyzer (Germany) using a homogeneous enzymatic colorimetric assay. A kit from GenoChem world was used to measure the MDA levels via a colorimetric analysis technique Sandwich enzyme-linked immunosorbent assay (ELISA) was used to determine the serum levels of Trx and 4-HNE.
Results: The results revealed significantly elevated levels of MDA and 4-HNE in preeclamptic women compared to their healthy counterparts (P<0.001). Although Trx levels did not differ significantly (P=0.29), marked distinctions were observed in LDL-C, TC, HDL-C, systolic and diastolic blood pressure (P<0.001). Preeclamptic women exhibited substantially higher LDL, TC, and blood pressure, and lower HDL.
Conclusion: This study highlights the correlation between elevated oxidative stress markers and an elevated risk of preeclampsia in pregnant women, which may suggest the impact of these markers in the pathogenesis of preeclampsia. These findings underscore the need for a nuanced understanding of these markers to enhance prenatal care and facilitate targeted interventions
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)control group comprising 45 healthy pregnant women |
| Preeclampsia group | – | Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)Preeclampsia group 45 women with preeclampsia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 45 with preeclampsia who completed the questionnaire, providing all necessary data
Key inclusion criteria (1 listed)
- Inclusion criteria specified pregnant women aged 20 to 40, diagnosed with preeclampsia based on blood pressure and proteinuria
Key exclusion criteria (1 listed)
- applied to those with diabetes, liver or kidney diseases, cardiovascular diseases, or using specific supplements like vitamins A, C, and E.
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 |
|---|---|---|
| Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)Blood samples were collected from the antecubital vein and processed at the TrueLab medical laboratory. The whole blood was initially collected in plain tubes, and subsequently centrifuged to obtain serum samples. Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) Thioredoxin and 4-Hydroxynonenal quantification, malondialdehyde levels | Diagnostic test | Control group, Preeclampsia group |
Primary outcome
Oxadative stress parameters
Time frame: 7 months
Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde
Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde
Time frame: 7 months
Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde
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 12 Aug 2025.
- Individual participant dataSharing planned: Undecided. Consent forms
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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.
Doaa El-Bohy, PhD principal investigator
Al-Ahliyya Amman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE) and Oxidative Stress, run by Future University in Egypt at 1 site in Jordan.
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 1 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. 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?
Oxadative stress parameters (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.