PreeclampsiaNCT05591638
Docosahexaenoic Acid Serum Levels in Patients With Preeclampsia
An observational study of Preeclampsia, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
By comparing the blood levels of docosahexaenoic acid (DHA) in preeclamptic patients with normal pregnant women, we aim to reveal the relationship between these markers, which are known to be effective on metabolic function, and preeclampsia, and to contribute to future studies and possible treatment options Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2022to 30 May 2023
- 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 18 to 40 years
- Women only
- Adult
Study population: 18-40 years old pregnant women at 20-40 weeks of gestation with and without preeclampsia (study and control)
Who may be able to join
- Pregnant women between the ages of 18-40, singleton pregnancies, pregnant women with preeclampsia, healthy pregnant women who do not have a history of hypertension before and after pregnancy
Who cannot join
- Pregnant women diagnosed with chronic hypertension before pregnancy, pregnant women with hypertension before the 20th gestational week, multiple pregnancies, pregnant women with molar pregnancies, women with a body mass index (BMI) >30kg/m2, pregnant women with a history of birth complicated with chromosomal abnormalities, pre-pregnancy or during pregnancy Pregnant women diagnosed with diabetes mellitus, pregnant women diagnosed with chronic systemic diseases, especially rheumatological, renal and vascular diseases, pregnant women diagnosed with chorioamnionitis, pregnant women with polyhydramnios, maternal infection diagnosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Docosahexaenoic Acid Serum Levels in Patients With Preeclampsia and Control Group
By comparing the blood levels of docosahexaenoic acid (DHA) in preeclamptic patients with normal pregnant women, we aim to reveal the relationship between these markers, which are known to be effective on metabolic function, and preeclampsia, and to contribute to future studies and possible treatment options
Read the detailed description
The research is a prospective cross-sectional study to be conducted at Recep Tayyip Erdogan University Training and Research Hospital, Department of Obstetrics and Gynecology. The current treatments of the patients will not be changed and no medical treatment or interventional procedures will be applied to the patients for study purposes. After the patients are informed about the study, the consent form will be signed, indicating that they voluntarily participated in the study. Apart from the biochemical parameters required for the diagnosis and treatment of the patients, different parameters will not be considered. The supply of Docosahexaenoic Acid kits required for the study will be provided by the executive physician and the blood taken from the patients will be evaluated.
G * Power 3.1.9.7 program was used to calculate the sample size for this study. At 80% statistical power and α=0.05 significance level, the smallest required sample size was calculated as 86 (control 44- study: 42) when d=0.51 effect size was calculated according to t-test for independent groups. Considering that there may be missing data, 90 patients between the ages of 18-40 will be included in the study. There will be 45 patients diagnosed with preeclampsia in the study group. There will be 45 normal pregnant women in the control group.
Preeclamptic patient selection and classification will be made according to the 2019 diagnostic criteria of the American Society of Obstetrics and Gynecology (ACOG). Accordingly, the diagnosis of preeclampsia; After 20 weeks of gestation in a normotensive pregnant woman, hypertension (systolic ≥140 mmHg and/or diastolic ≥90 mmHg) proteinuria or thrombocytopenia with hypertension (platelet <100,000/103 /μL), impaired liver function tests (liver liver function) transaminase blood values to twice the normal concentration), new-onset renal failure (serum creatinine values > 1.1 mg/dL or a two-fold increase in serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral and visual acuity will be placed in case of malfunctions. proteinuria; Proteinuria ≥ 300 mg in 24-hour urine or protein/creatinine ratio ≥ 0.3 or 1+ proteinuria as measured by urine stick. The diagnosis of severe preeclampsia will be made when blood pressure values are systolic ≥160 mmHg and/or diastolic ≥110 mmHg.
Demographic, clinical and laboratory data of the pregnant women included in the study will be recorded. The last menstrual period, obstetric examination and ultrasonography findings will be taken as basis in the determination of the gestational week. For each patient, age, body mass index (BMI), number of births, week of birth, type of birth, birth weight, complete blood count (hemogram), liver function tests (AST, ALT), kidney function tests (urea, creatinine) and full Urine test results will be recorded. In order to avoid the possible effects of corticosteroid and MgSO4 treatments on laboratory parameters in preeclamptic pregnant women, the first laboratory results at hospitalization will be taken into account. In addition, 1st and 5th minute APGAR scores will be noted to assess perinatal outcomes.
Inclusion criteria: Pregnant women aged 18-40, singleton pregnancies, pregnant women with preeclampsia, healthy pregnant women without a history of hypertension before and after pregnancy
Exclusion criteria:
Pregnant women diagnosed with chronic hypertension before pregnancy, pregnant women with hypertension before the 20th gestational week, multiple pregnancies, pregnant women with molar pregnancies, women with a body mass index (BMI) >30kg/m2, pregnant women with a history of birth complicated with chromosomal abnormalities, pre-pregnancy or during pregnancy Pregnant women diagnosed with diabetes mellitus, pregnant women diagnosed with chronic systemic diseases, especially rheumatological, renal and vascular diseases, pregnant women diagnosed with chorioamnionitis, pregnant women with polyhydramnios, maternal infection diagnosis.
In the study, since the medical treatment of the patients was not changed and additional medical treatment and interventional procedures were not applied, it would not be necessary to take safety precautions. The blood taken from the patients for routine diagnosis and treatment will be stored at -20 degrees Celsius after the serum and plasma are separated. By comparing the blood levels of docosahexaenoic acid (DHA) in preeclamptic patients with normal pregnant women, the relationship between these markers, which are known to be effective on metabolic function, and preeclampsia will be evaluated. Afterwards, follow-up, treatment and laboratory evaluation for study purposes are not required.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, docosahexaenoic acid, fatty acids, omega-3
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | There will be 45 patients diagnosed with preeclampsia in the study group | |
| GROUP 2 | There will be 45 normal pregnant women in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
docosahexaenoic acid
docosahexaenoic acid levels between groups will be measured
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start24 Oct 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senol Senturk, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- SENOL SENTURK, Study director, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591638
- Sponsor's protocol ID
- 2022/169
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Docosahexaenoic Acid Serum Levels in Patients With Preeclampsia and Control Group
- ClinicalTrials.gov ID
- NCT05591638
- Acronym / sponsor ID
- 2022/169
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, docosahexaenoic acid, fatty acids, omega-3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 24 Oct 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 24 Oct 2022 (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.
By comparing the blood levels of docosahexaenoic acid (DHA) in preeclamptic patients with normal pregnant women, we aim to reveal the relationship between these markers, which are known to be effective on metabolic function, and preeclampsia, and to contribute to future studies and possible treatment options
Detailed description
The research is a prospective cross-sectional study to be conducted at Recep Tayyip Erdogan University Training and Research Hospital, Department of Obstetrics and Gynecology. The current treatments of the patients will not be changed and no medical treatment or interventional procedures will be applied to the patients for study purposes. After the patients are informed about the study, the consent form will be signed, indicating that they voluntarily participated in the study. Apart from the biochemical parameters required for the diagnosis and treatment of the patients, different parameters will not be considered. The supply of Docosahexaenoic Acid kits required for the study will be provided by the executive physician and the blood taken from the patients will be evaluated.
G * Power 3.1.9.7 program was used to calculate the sample size for this study. At 80% statistical power and α=0.05 significance level, the smallest required sample size was calculated as 86 (control 44- study: 42) when d=0.51 effect size was calculated according to t-test for independent groups. Considering that there may be missing data, 90 patients between the ages of 18-40 will be included in the study. There will be 45 patients diagnosed with preeclampsia in the study group. There will be 45 normal pregnant women in the control group.
Preeclamptic patient selection and classification will be made according to the 2019 diagnostic criteria of the American Society of Obstetrics and Gynecology (ACOG). Accordingly, the diagnosis of preeclampsia; After 20 weeks of gestation in a normotensive pregnant woman, hypertension (systolic ≥140 mmHg and/or diastolic ≥90 mmHg) proteinuria or thrombocytopenia with hypertension (platelet <100,000/103 /μL), impaired liver function tests (liver liver function) transaminase blood values to twice the normal concentration), new-onset renal failure (serum creatinine values > 1.1 mg/dL or a two-fold increase in serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral and visual acuity will be placed in case of malfunctions. proteinuria; Proteinuria ≥ 300 mg in 24-hour urine or protein/creatinine ratio ≥ 0.3 or 1+ proteinuria as measured by urine stick. The diagnosis of severe preeclampsia will be made when blood pressure values are systolic ≥160 mmHg and/or diastolic ≥110 mmHg.
Demographic, clinical and laboratory data of the pregnant women included in the study will be recorded. The last menstrual period, obstetric examination and ultrasonography findings will be taken as basis in the determination of the gestational week. For each patient, age, body mass index (BMI), number of births, week of birth, type of birth, birth weight, complete blood count (hemogram), liver function tests (AST, ALT), kidney function tests (urea, creatinine) and full Urine test results will be recorded. In order to avoid the possible effects of corticosteroid and MgSO4 treatments on laboratory parameters in preeclamptic pregnant women, the first laboratory results at hospitalization will be taken into account. In addition, 1st and 5th minute APGAR scores will be noted to assess perinatal outcomes.
Inclusion criteria: Pregnant women aged 18-40, singleton pregnancies, pregnant women with preeclampsia, healthy pregnant women without a history of hypertension before and after pregnancy
Exclusion criteria:
Pregnant women diagnosed with chronic hypertension before pregnancy, pregnant women with hypertension before the 20th gestational week, multiple pregnancies, pregnant women with molar pregnancies, women with a body mass index (BMI) >30kg/m2, pregnant women with a history of birth complicated with chromosomal abnormalities, pre-pregnancy or during pregnancy Pregnant women diagnosed with diabetes mellitus, pregnant women diagnosed with chronic systemic diseases, especially rheumatological, renal and vascular diseases, pregnant women diagnosed with chorioamnionitis, pregnant women with polyhydramnios, maternal infection diagnosis.
In the study, since the medical treatment of the patients was not changed and additional medical treatment and interventional procedures were not applied, it would not be necessary to take safety precautions. The blood taken from the patients for routine diagnosis and treatment will be stored at -20 degrees Celsius after the serum and plasma are separated. By comparing the blood levels of docosahexaenoic acid (DHA) in preeclamptic patients with normal pregnant women, the relationship between these markers, which are known to be effective on metabolic function, and preeclampsia will be evaluated. Afterwards, follow-up, treatment and laboratory evaluation for study purposes are not required.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | – | –There will be 45 patients diagnosed with preeclampsia in the study group |
| GROUP 2 | – | –There will be 45 normal pregnant women in the control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 18-40 years old pregnant women at 20-40 weeks of gestation with and without preeclampsia (study and control)
Key inclusion criteria (1 listed)
- Pregnant women between the ages of 18-40, singleton pregnancies, pregnant women with preeclampsia, healthy pregnant women who do not have a history of hypertension before and after pregnancy
Key exclusion criteria (1 listed)
- Pregnant women diagnosed with chronic hypertension before pregnancy, pregnant women with hypertension before the 20th gestational week, multiple pregnancies, pregnant women with molar pregnancies, women with a body mass index (BMI) >30kg/m2, pregnant women with a history of birth complicated with chromosomal abnormalities, pre-pregnancy or during pregnancy Pregnant women diagnosed with diabetes mellitus, pregnant women diagnosed with chronic systemic diseases, especially rheumatological, renal and vascular diseases, pregnant women diagnosed with chorioamnionitis, pregnant women with polyhydramnios, maternal infection diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
docosahexaenoic acid
Time frame: 6 months
docosahexaenoic acid levels between groups will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
SENOL SENTURK study director
Recep Tayyip Erdogan University
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Recep Tayyip Erdogan University Training and Research Hospital.
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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SENOL SENTURK (+905327166482, dr.senturk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
docosahexaenoic acid (time frame: 6 months). 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 24 Oct 2022.