Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05591638 |
| Other study ID # |
2022/169 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 24, 2022 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Recep Tayyip Erdogan University Training and Research Hospital |
| Contact |
SENOL SENTURK |
| Phone |
+905327166482 |
| Email |
dr.senturk[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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.
