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PreeclampsiaNCT05591638

Docosahexaenoic Acid Serum Levels in Patients With Preeclampsia

An observational study of Preeclampsia, run by Recep Tayyip Erdogan University Training and Research Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 groups in NCT05591638
Study groupRoleWhat they receive
GROUP 1There will be 45 patients diagnosed with preeclampsia in the study group
GROUP 2There 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.

  1. 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.

  1. First posted24 Oct 2022
  2. Study start24 Oct 2022 (estimated)
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 May 2023 (estimated)

Resources

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)
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

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.

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