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Search / Trial NCT06876051

Prenatal Intervention of Maternal Stress - Breastfeeding & Infant Neurodevelopment

Launched by NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS · Mar 7, 2025

Trial Information

Current as of April 26, 2025

Completed

Keywords

Breastfeeding Bdnf Reelin Pregnancy Relaxation Techniques Stress Management

ClinConnect Summary

METHODOLOGY Researchers will compare three groups of pregnant women who will receive three different types of information during pregnancy.

* The first group, or intervention group (IG), will be trained in 8-10 structured individual sessions of relaxation techniques that they will apply throughout the pregnancy, along with structured information about breastfeeding.
* The second group, or Active Control group (ACG), will receive 8 individual structured educational courses about breastfeeding, childbirth and the needs of the newborn, and
* The third group, or Control Group (CG), will receiv...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Primiparous pregnant women
  • 14-20 weeks of Gestational Age
  • Intention to give birth at the specific maternity hospital
  • Greek women or foreigners who know the Greek language very well
  • Place of residence: Greece
  • Exclusion Criteria:
  • Use of benzodiazepines, major neuroleptics, or psychostimulant medications.
  • Pregnant women diagnosed with incurable physical or mental diseases.
  • Pregnant women carrying fetuses or newborns with major congenital anomalies or criteria for perinatal asphyxia.
  • Pregnant women with stillbirths or newborns who do not survive.
  • All mothers and their newborns born before 34 weeks of gestation or requiring hospitalization in the Neonatal Intensive Care Unit (NICU) for more than 7 days.

About National And Kapodistrian University Of Athens

The National and Kapodistrian University of Athens is a prestigious academic institution in Greece, renowned for its commitment to advancing medical research and education. With a strong emphasis on interdisciplinary collaboration, the university fosters innovative clinical trials aimed at improving healthcare outcomes. Its dedicated research teams leverage cutting-edge methodologies and a diverse range of expertise to address critical health challenges. As a clinical trial sponsor, the university prioritizes ethical standards and the welfare of participants, contributing significantly to the global body of medical knowledge and the development of new therapeutic interventions.

Locations

Athens, Attica, Greece

Patients applied

0 patients applied

Trial Officials

Tania Siahanidou Associate Professor in Pediatrics - Neonatology, MD, PhD

Study Director

1st_Dept.of Pediatrics_Athens_University_Medical School_Aghia Sophia_Children's Hosp_Athens_11527_GR

Aikaterini Fotiou, MD, MSc

Principal Investigator

Neonatal Dept_Maternity Hosp_Elena Venizelou_2_Plateia Elenas Venizelou Str_Athens 115 21_GR

George P. Chrousos Prof. Emeritus of Pediatrics & Endocrinology_Academician, MD, MACP, MACE

Study Chair

National & Kapodistrian Univ. of Athens_Research_Inst. for Mother-Child Health_Aghia Sophia_Hosp.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported