Fetal Fornix and Hippocampus in Pregnant Women With Early-Onset Preeclampsia

NCT07245056 | Recruiting

• 1 other identifier: AEŞH-BADEK2-2025-551
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Eclampsia; Hippocampus

Keywords

fetal brain; fornix; hippocampus; early-onset preeclampsia

Outcome Measures

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)

  Until completion of participant recruitment (approximately 7 months).

Secondary Outcomes (1)

• Correlation between fetal FHC and hippocampus height measurements and composite adverse perinatal outcomes

  Until completion of participant recruitment (approximately 7 months).

Study Arms (1)

One arm (fetal FHC measurements for EOPE and control groups)

OTHER

One arm for fetal fornix and hippocampus complex (FHC) measurements on early-onset preeclampsia (EOPE) and control groups

Other: FHC dimensions in EOPE and control groups

Interventions

FHC dimensions in EOPE and control groups OTHER

Fetal fornix and hippocampus complex (FHC) dimension changes on EOPE and control groups

One arm (fetal FHC measurements for EOPE and control groups)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years
• Gestational age between 20 and 34 weeks
• Diagnosis of early-onset preeclampsia (EOPE)
• Singleton pregnancy

You may not qualify if:

• 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
• Tobacco or alcohol use during pregnancy
• Maternal late-onset preeclampsia (≥34 weeks gestation)

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Zhang H, Lin J, Zhao H. Impacts of Maternal Preeclampsia Exposure on Offspring Neuronal Development: Recent Insights and Interventional Approaches. Int J Mol Sci. 2024 Oct 15;25(20):11062. doi: 10.3390/ijms252011062.

  PMID: 39456854 BACKGROUND

• Johnson AC, Li Z, Orfila JE, Herson PS, Cipolla MJ. Hippocampal network dysfunction as a mechanism of early-onset dementia after preeclampsia and eclampsia. Prog Neurobiol. 2021 Apr;199:101938. doi: 10.1016/j.pneurobio.2020.101938. Epub 2020 Oct 29.

  PMID: 33130230 BACKGROUND

• Johnson AC, Tremble SM, Cipolla MJ. Experimental Preeclampsia Causes Long-Lasting Hippocampal Vascular Dysfunction and Memory Impairment. Front Physiol. 2022 May 9;13:889918. doi: 10.3389/fphys.2022.889918. eCollection 2022.

  PMID: 35615682 BACKGROUND

• Sadeghi A, Asghari H, Hami J, Mohasel Roodi M, Mostafaee H, Karimipour M, Namavar M, Idoon F. Volumetric investigation of the hippocampus in rat offspring due to diabetes in pregnancy-A stereological study. J Chem Neuroanat. 2019 Nov;101:101669. doi: 10.1016/j.jchemneu.2019.101669. Epub 2019 Aug 20.

  PMID: 31442582 BACKGROUND

• Arica G, Davutoglu EA, Buldum D, Kucuksuleymanoglu D, Najmeddin S, Madazli R. Fetal Fornix-Hippocampus Complex and Hippocampus Height Measurements Between 18 and 24 Weeks of Gestation and the Effect of Maternal Iron Deficiency Anemia. J Clin Ultrasound. 2025 Jul-Aug;53(6):1288-1295. doi: 10.1002/jcu.24008. Epub 2025 Apr 16.

  PMID: 40237113 RESULT

• Gindes L, Weissmann-Brenner A, Weisz B, Zajicek M, Geffen KT, Achiron R. Identification of the fetal hippocampus and fornix and role of 3-dimensional sonography. J Ultrasound Med. 2011 Dec;30(12):1613-8. doi: 10.7863/jum.2011.30.12.1613.

  PMID: 22123994 RESULT

• Sahin NE, Alici Davutoglu E, Arica G, Madazli R. Identification of bilateral fornix and hippocampus in fetuses between 18-36 gestational weeks and establishment of nomograms using ultrasonography. Arch Gynecol Obstet. 2025 Aug;312(2):627-634. doi: 10.1007/s00404-025-08061-z. Epub 2025 May 23.

  PMID: 40407880 RESULT

• Toprak E, Sayal HB. Ultrasonographic imaging of the fetal hippocampus. Arch Gynecol Obstet. 2024 May;309(5):1943-1949. doi: 10.1007/s00404-023-07093-7. Epub 2023 Jun 9.

  PMID: 37294452 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

eosinylphosphatidylethanolamine; Control Groups

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Seyit A Erol, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyit A Erol, MD

CONTACT

+0903127970000; gyn.aerol@gmail.com

Kadriye Yakut Yucel, MD

CONTACT

+0903127970000; yakutkadriye@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)