Fetal Fornix and Hippocampus in Pregnant Women With Early-Onset Preeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAnkara Etlik City Hospital
About this trial
Since early-onset preeclampsia (EOPE) is commonly associated with inadequate placentation, placental insufficiency, chronic fetal hypoxia, oxidative stress, and heightened inflammation, these pathological processes may adversely affect hippocampal neuronal development and maturation of axonal pathways such as the fornix. These mechanisms support our hypothesis that fetal fornix and hippocampus dimensions may be reduced in pregnancies complicated by EOPE, forming the scientific basis of our study.
Previous research has suggested a potential link between preeclampsia (PE) and altered neurocognitive development. However, no studies to date have specifically evaluated the relationship between EOPE and fetal fornix or hippocampus dimensions. Therefore, the objective of our study is to assess fetal fornix and hippocampus measurements in pregnant women with early-onset preeclampsia compared with healthy controls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18-45 years
Gestational age between 20 and 34 weeks
Diagnosis of early-onset preeclampsia (EOPE)
Singleton pregnancy
Disqualifiers
Multiple pregnancies
Presence of chronic or significant comorbid conditions other than maternal early-onset preeclampsia, including: Chronic, mental, or physical illnesses, severe renal, hepatic, or gastrointestinal acute or chronic inflammatory diseases, hyperthyroidism or hypothyroidism, chronic hypertension, type 1 or type 2 diabetes mellitus, history of polycystic ovary syndrome (PCOS), history of malignancy
Fetal congenital or chromosomal anomalies
Chronic medication use
Trial design
Design model
Single group
Treatments tested in this trial
FHC dimensions in EOPE and control groups
Other interventionFetal fornix and hippocampus complex (FHC) dimension changes on EOPE and control groups
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: One arm (fetal FHC measurements for EOPE and control groups)Other 1 intervention
Trial outcomes
Primary outcomes
1
Fetal fornix-hippocampus complex (FHC) dimensions (mm)
Measurement of fetal fornix-hippocampus complex (FHC) length and hippocampus height using two-dimensional ultrasonography (2D-US) in pregnancies complicated by early-onset preeclampsia (EOPE) compared with healthy controls. Unit of Measure: Millimeters (mm) Measurement Tool: Two-dimensional ultrasonography (2D-US)
Time frame
Until completion of participant recruitment (approximately 7 months).Secondary outcomes
1
Correlation between fetal FHC and hippocampus height measurements and composite adverse perinatal outcomes
Assessment of the correlation between fetal Fornix-Hippocampus Complex (FHC) and hippocampus height measurements obtained by 2D ultrasonography and composite adverse perinatal outcomes, specifically preterm birth \<34 weeks (reported as both absolute number and percentage), fetal growth restriction (FGR), NICU admission, and low Apgar scores. Unit of Measure: Correlation coefficient (r) Measurement Tools: * FHC and hippocampus height measurements by 2D ultrasonography * Perinatal outcome data obtained at delivery
Time frame
Until completion of participant recruitment (approximately 7 months).Sponsors and contacts
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Source ClinicalTrials.gov