Prenatal Intervention of Maternal Stress - Breastfeeding & Infant Neurodevelopment

Summary

The goal of this clinical trial is to determine whether antenatal maternal stress management using relaxation techniques improves breastfeeding effectiveness and neonatal neurodevelopmental outcomes. It is hypothesized that reducing maternal stress during pregnancy will enhance the initiation and continuation of exclusive breastfeeding until six months postpartum.

The management of antenatal maternal stress is expected to be reflected in both the newborn's behavior and proteins associated with neurodevelopment, such as Brain-Derived Neurotrophic Factor (BDNF) and Reelin.

The main research questions of this study include the following:

1. Does stress management in pregnant women using relaxation techniques increase the likelihood of exclusive breastfeeding at one and six months postpartum?
2. Does it impact neonatal and infant growth and behavior?
3. Does it alter neurotrophin levels in the fetus? This trial will provide insight into the potential benefits of prenatal stress reduction for both maternal and infant health outcomes.
4. "If prenatal stress management leads to changes in neurotrophins in the fetus, could these changes be linked to the success and duration of breastfeeding, as well as the infant's growth and behavior?

Conditions

• Stress
• Relaxation
• Breastfeeding
• Infant Behavior
• Prenatal Stress

Interventions

BEHAVIORAL

Relaxation & Breastfeeding Education

Pregnant women in this group will be trained in 10 individual interactive sessions, focusing on relaxation techniques and breastfeeding including: 1. Diaphragmatic breathing 2. Progressive muscle relaxation (PMR) - tailored for pregnant women. 3. Guided imagery 4. the analysis of the concept of stress and stress management strategies for pregnancy including Cognitive-behavioral approach (CBT principles) 5. Mindfulness-based pregnancy adaptation including positive thinking and wellbeing during pregnancy . 6. Pregnancy stages. 7. Benefits of breastfeeding. 8. Breastfeeding guide and practical applications. 9. Labor stages and childbirth preparation. 10. Newborn and infant needs at home Every relaxation technique training will last 20 minutes practice in every session Additionally pregnant women will be practiced at least 3 times weekly during pregnancy

BEHAVIORAL

Active comparator

Participants in this group will receive only interactive online education, focusing exclusively on breastfeeding and newborn care. The Programme included ten remote sessions: 1. Pregnancy stages. 2. Benefits of breastfeeding. 3. Skin-to-skin contact and rooming-in during the first days. 4. The role of breastfeeding in maternal emotional well-being. 5. Breastfeeding guide and practical applications. 6. Maternal nutrition during breastfeeding. 7. Common breastfeeding challenges. 8. The father's role in breastfeeding support. 9. Labor stages and childbirth preparation 10. Newborn and infant needs at home.

OTHER

control group

This group will received only standard prenatal and postnatal care at a Baby-Friendly Hospital, which adheres to WHO and UNICEF guidelines for breastfeeding support. They did not participate in additional structured educational programs or relaxation training.

Sponsors & Collaborators

• General and Maternity Hospital of Athens Elena Venizelou

  collaborator OTHER

• National and Kapodistrian University of Athens

  lead OTHER

Principal Investigators

• Tania Siahanidou Associate Professor in Pediatrics - Neonatology, MD, PhD · 1st_Dept.of Pediatrics_Athens_University_Medical School_Aghia Sophia_Children's Hosp_Athens_11527_GR

• Aikaterini Fotiou, MD, MSc · 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 · National & Kapodistrian Univ. of Athens_Research_Inst. for Mother-Child Health_Aghia Sophia_Hosp.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-01

Primary Completion

2023-12-15

Completion

2024-09-10

Countries

• Greece

Study Locations