Prenatal Intervention of Maternal Stress - Breastfeeding & Infant Neurodevelopment
NCT ID: NCT06876051
Last Updated: 2025-03-14
Study Results
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Basic Information
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COMPLETED
NA
162 participants
INTERVENTIONAL
2018-02-01
2024-09-10
Brief Summary
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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?
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Detailed Description
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* 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 receive a standard use information provided by the hospital midwife stuff about childbirth and breastfeeding in 3-4 group meetings .
Participants will be primipara pregnant women native speaking of the Greek language and they will be included in the study after randomization based on the electronic system random.org , between the 15th and 20th week of gestation They will be studied in 4 time periods (phases) .
* The first phase, will be prenatally at the beginning of the study between 15th -20th week of gestation,
* the second phase, will be prenatally at the end of the study between the 34th and 36th week of gestation,
* the third phase, will be in the first month after childbirth and
* the fourth phase, will be in the 6th month of their baby's life. The study as well, will include the newborns of the participants in the third and fourth phase of the study, corresponding them to the group of their mothers.
Comparisons will be in each group and between the groups investigating the alteration of stress, anxiety and depression during the four time periods pre and postnatally . Concurrently the change in the belief of successful breastfeeding during the two first periods of time (phase 1 and 2 ) , prenatally, will be compared with the real outcome at the phase 3 and 4.
For each participant, the following data will be recorded:
Phases 1 and 2:
1. Demographic data
2. Pregnancy stress, assessed using the Prenatal Experience Brief Scale
3. Pregnancy anxiety, assessed using the Pregnancy Anxiety Questionnaire
4. Prenatal breastfeeding self-efficacy, assessed using the Prenatal e. Breastfeeding Self-Efficacy Scale
Phases 1, 2, 3, and 4:
1. Perceived stress, assessed using the Perceived Stress Scale-14 (PSS-14)
2. Postpartum depression, assessed using the Edinburgh Postpartum Depression Scale (EPDS)
3. Anxiety, assessed using the Spielberger State-Trait Anxiety Inventory (STAI)
Phases 3 and 4:
1. Breastfeeding self-efficacy, assessed using the Breastfeeding Self-Efficacy Scale
2. Breastfeeding-related questions from the Pregnancy Risk Assessment Monitoring System (PRAMS) of the CDC
Phase 4 only :
1. Maternal attachment, assessed using the Maternal Attachment Scale
2. Infant behavior, assessed using the Infant Behavior Questionnaire
For each newborn, the following data will be recorded:
1. Anthropometric measurements at birth (3rd phase) and at six months of age (4th phase).
2. Neonatal behavior, assessed between the 4th and 7th day of life (3rd phase) using the Neonatal Behavioral Assessment Scale (NBAS). The evaluation will be conducted by a healthcare professional trained and familiar with the use of this specific behavioral assessment tool.
3. Developmental milestones at six months of age (4th phase).
4. Infant behavior assessment at six months of age (4th phase), conducted using the Infant Behavior Questionnaire, which will be completed by the parents based on their own observations and assessment
Biological Markers Collection and Analysis
The collection of biological markers is structured according to the study phase:
* In phases 1 and 2, salivary cortisol will be measured in pregnant participants. Participants will be asked to collect saliva using Salivettes (Sarstedt), following specific instructions provided by the manufacturer.
* In phases 1 and 3, maternal serum neurotrophins (BDNF and Reelin) will be analyzed. Additionally, in phase 3, umbilical cord serum neurotrophins will be measured.
Saliva Collection and Analysis
Saliva collection will be conducted at four time points throughout the day to assess the circadian rhythm of each pregnant participant:
* Morning, immediately upon awakening
* 30 minutes after awakening
* Afternoon, before lunch (around 3:00 PM)
* Night, before bedtime (around 12:00 AM) Pregnant participants will store the collected samples in the refrigerator until they bring them to the laboratory the following day. At the laboratory, the samples will undergo centrifugation followed by measurement using Chromatography/Mass Spectrometry.. The saliva samples will be centrifuged for 2 minutes at 1,000 × g, following the manufacturer's instructions.
Neurotrophin Measurement (BDNF \& Reelin) - Phases 1 and 3
The measurement of BDNF and Reelin neurotrophins will be performed on serum blood samples collected at three time points:
1. Phase 1: At the start of the intervention (between 15-20 weeks of gestation) - maternal blood serum.
2. Phase 3: Before delivery (at hospital admission, marking the end of the prenatal intervention) - maternal blood serum.
3. Phase 3: During delivery - umbilical cord serum only. All blood samples will undergo centrifugation at 3500 rpm for 5-6 minutes. The separated serum will then be transferred into Eppendorf tubes and stored at -80°C until further analysis. Neurotrophin levels (BDNF \& Reelin) will be measured using the ELISA method.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Behavioral: Relaxation & Breastfeeding Education
Participants in the intervention group (primiparous pregnant women) receive:
1. Training in relaxation techniques, including guided breathing exercises, progressive muscle relaxation, and visualization methods.
2. Breastfeeding education, covering topics such as proper latching, milk production, and infant feeding schedules.
The intervention consists of 8-10 structured sessions, beginning in the second trimester (gestational weeks 15-20) and continuing until the 36th week of gestation. Sessions are conducted in a structured format by trained professionals.
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 : Breastfeeding Education Alone
Participants in the Active Comparator group receive 8-10 individual lessons covering: Pregnancy education, Breastfeeding techniques and best practices, Childbirth preparation, Newborn care essentials, Understanding infant cues and responses.
These sessions are delivered in a structured format by trained professionals. No relaxation techniques are included in this intervention.
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.
Standard Maternity Care (Control Group)
Participants in the control group receive only the standard maternity care provided by health services during pregnancy.
The maternity hospital is designated as a Baby-Friendly Hospital and follows its established guidelines and principles.
Standard care includes routine prenatal check-ups and general health services. The hospital also offers psycho-prophylactic preparation for normal childbirth and one breastfeeding course, both led by midwife trainers.
No additional intervention, such as relaxation techniques or structured breastfeeding education, is provided to this group.
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.
Interventions
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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
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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General and Maternity Hospital of Athens Elena Venizelou
OTHER
National and Kapodistrian University of Athens
OTHER
Responsible Party
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Aikaterini Fotiou
MD, MSc, Pediatrician -Neonatologist, Director of Neonatal Dept/NICU, General and Maternity Hospital "Helena Venizelou", Athens, Greece
Principal Investigators
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Tania Siahanidou Associate Professor in Pediatrics - Neonatology, MD, PhD
Role: STUDY_DIRECTOR
1st_Dept.of Pediatrics_Athens_University_Medical School_Aghia Sophia_Children's Hosp_Athens_11527_GR
Aikaterini Fotiou, MD, MSc
Role: 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
Role: STUDY_CHAIR
National & Kapodistrian Univ. of Athens_Research_Inst. for Mother-Child Health_Aghia Sophia_Hosp.
Locations
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Maternity Hospital "ELENA VENIZELOU"
Athens, Attica, Greece
Countries
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References
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Study Documents
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Document Type: Peer-reviewed journal publication related to the study
Greek Validation of the Questionnaire "Prenatal Breast-Feeding Self Efficacy" Scale July 2024Journal of Pediatrics Research Reviews \& Reports
View DocumentDocument Type: Peer-reviewed journal publication related to the study
Title: The effect of body and mind stress-releasing techniques on the breastfeeding of full term babies; a critical analysis of published interventional studies
View DocumentOther Identifiers
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ID 126/04-09-17
Identifier Type: OTHER
Identifier Source: secondary_id
1617031875/2017
Identifier Type: OTHER
Identifier Source: secondary_id
1617031875 / 04-07-17
Identifier Type: -
Identifier Source: org_study_id
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