The Impact of Prenatal Stress Management Program on Maternal Breastfeeding and Neonatal Neurodevelopmental Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Prenatal Breastfeeding Self-Efficacy Across Study Groups
研究概览
简要总结
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:
- Does stress management in pregnant women using relaxation techniques increase the likelihood of exclusive breastfeeding at one and six months postpartum?
- Does it impact neonatal and infant growth and behavior?
- 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.
- "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?
详细描述
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Behavioral: Relaxation & Breastfeeding Education
Participants in the intervention group (primiparous pregnant women) receive:
- Training in relaxation techniques, including guided breathing exercises, progressive muscle relaxation, and visualization methods.
- 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.
干预措施: Relaxation & Breastfeeding Education (Behavioral)
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.
干预措施: Active comparator (Behavioral)
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.
干预措施: control group (Other)
结局指标
主要结局
Prenatal Breastfeeding Self-Efficacy Across Study Groups
时间窗: 1) between 15 - 20 week of gestation and 2) between 35-38 weeks gestation before child birth
This outcome will assess maternal confidence in breastfeeding and actual breastfeeding before childbirth using the Prenatal Breastfeeding Self-Efficacy Scale (PBSES), a validated tool that measures prenatal maternal perceived ability to breastfeed successfully. The PBSES consists of 20 items rated on a 5-point Likert scale, with a SUM score ranging from 20 (minimum) to 100 (maximum). Scores will be recorded without a cutoff point, with higher scores indicating greater prenatal maternal confidence in breastfeeding. Comparisons will be conducted among the three study groups to evaluate differences in PBSES scores based on the intervention received. Statistical analysis will include the comparisons across study groups using ANOVA or non-parametric equivalents. Regression models to explore potential predictors of higher or lower prenatal self-efficacy.
Breastfeeding Self-Efficacy across the study groups and the time frames
时间窗: At 1 and 6 months postpartum
Maternal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale (BSES), a validated questionnaire measuring maternal confidence in breastfeeding. The BSES consists of 14 items, each rated on a 5-point scale (1 = Strongly Disagree, 5 = Strongly Agree). The final score is calculated as the sum of all item scores, with higher scores indicating greater breastfeeding self-efficacy. Minimum Value is 14 (lowest BSES score) and Maximum Value is70 (highest BSES score) Comparative analyses will be conducted across the three study groups to evaluate differences in self-efficacy levels.
Breastfeeding Outcomes Across Study Groups
时间窗: at 1 and 6 Months Postpartum
Breastfeeding outcomes will be derived from responses to selected PRAMS questions, which indirectly indicate exclusivity. Breastfeeding success will be numerically categorized (1 = Exclusive breastfeeding, 2 = Any breastfeeding, 3 = No breastfeeding) to allow for statistical comparison with Breastfeeding Self-Efficacy Scale (BSES) scores. The analysis will examine whether higher BSES scores are associated with exclusive or any breastfeeding.
Neurotrophin Levels as Neurodevelopmental Parameters in Maternal Serum and Umbilical Cord Blood across the study groups
时间窗: In Maternal serum: 1) between the 15th -20th weeks of gestation and 2) at 36-37 weeks of gestation .Additionally Neurotrophins will be measured In Umbilical cord blood: At birth
The levels of neurotrophins, specifically brain-derived neurotrophic factor (BDNF) and Reelin, will be assessed as neurodevelopmental biomarkers in maternal serum at 15-20 weeks and 36-37 weeks of gestation, and in umbilical cord blood at birth. Neurotrophin quantification will be performed using the Enzyme-Linked Immunosorbent Assay (ELISA) method, following standardized protocols. Results will be expressed in picograms per milliliter (pg/mL), and comparative analyses will be conducted to evaluate differences across the three study groups and at different time points.
Neonatal Behavioral Assessment Across Study Groups
时间窗: 4-7 days postpartum
Neonatal behavior will be assessed using the Neonatal Behavioral Assessment Scale (NBAS), conducted by a personnel trained in administering and scoring the instrumental tool . NBAS contains a large number of individual items scored on a 9-point scale and reflexes scored on a 4-point scale . The evaluated items will be categorized into eight clusters, with scores representing the mean of the item scores within each cluster. The clusters and the number of items per cluster are: 1. Habituation (4 items) , 2. Social -Interactive (7 items) , 3. Motor System (5 items), 4. State Organization(4 items), 5. State Regulation (4 items), 6. Autonomic System (3 items) , 7. Reflexes (18 items), 8. Supplementary Items (7 items)-Additional behavioral observations.
Infant Behavioral Assessment Across Study Groups
时间窗: IBQ-R SF will be measured at 6 months postpartum
Infant behavior will be assessed using the Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), completed by parents. The IBQ-R SF consists of 91 items, each rated on a 7-point Likert scale (1 = Never, 7 = Always). Scores are averaged within each of the 14 behavioral subscales, which are further grouped into three broad temperament dimensions. The final score for each subscale or dimension is calculated as the mean of the corresponding item scores, providing a standardized numerical measurement of infant temperament for comparative analyses across the three study groups.
次要结局
- Correlation Between Maternal age and Breastfeeding success(breastfeeding outcomes : at 1 and 6 month postpartum.)
- Correlation Between Maternal Socioeconomic Status and Breastfeeding success(Household income will be assessed between the 15th and 20th week of gestation, while breastfeeding outcomes will be measured at 1 and 6 months postpartum.)
- correlation of maternal Body Mass Index (BMI) and Breastfeeding success across the three study groups.(BMI assessment: Pre-pregnancy (self-reported) and at delivery (clinically measured) Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Correlation Between Anxiety and Breastfeeding success(STAI assessment: prenatally at 15-20 and 35-38 weeks of gestation . Postnatally, Breastfeeding outcomes assessment: at 1 and 6 months postpartum.)
- Correlation Between Pregnancy-Related Anxiety (PRAQ-R2) and Breastfeeding Success across study groups(PRAQ-R2 assessment: Between 15-20 and 35-38 weeks of gestation Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Influence of Neonatal Behavior on Breastfeeding Outcomes(NBAS is evaluating between the first 4-7 days of life. Breastfeeding assessment will be at 1 and 6 months postpartum)
- Correlation Between Neurotrophin Levels and Breastfeeding Self-Efficacy across the study groups(Neurotrophin levels: Maternal serum (15-20 and 36-37 weeks gestation), Umbilical cord blood (at birth) Breastfeeding self-efficacy: 1 and 6 months postpartum)
- Correlation between Prenatal Breastfeeding Self-Efficacy and Breastfeeding Outcomes Across Study Groups(PBSES assessment: 15-20 weeks and 35-38 weeks of gestation Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Correlation between Postnatal Breastfeeding Self-Efficacy and Breastfeeding Outcomes Across Study Groups(BSES assessment: 1 and 6 months postpartum Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Correlation between Salivary Cortisol levels and Breastfeeding outcomes across the study groups(Salivary cortisol levels at 35-38 week of gestation . Breastfeeding success at 1 month postpartum)
- Correlation Between Infant Behavior and Breastfeeding Success across the three study groups(IBQ-R SF assessment: 6 months postpartum Breastfeeding outcomes assessment: 6 months postpartum)
- correlation between newborn hospitalization and breastfeeding success across the study groups(Neonatal hospitalization assessment: At birth Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Correlation of Breastfeeding difficulties and postpartum breastfeeding support with breastfeeding success across the study groups(Assessment of breastfeeding difficulties and postpartum support: 4 days postpartum Breaffeidng success at 1 and 6 months after birth)
- Correlation Between Mode of Delivery and Breastfeeding Success across the study groups(Mode of delivery assessment: At birth Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Correlation Between Postpartum Depression (EPDS) and Breastfeeding Success across the study groups(EPDS assessment: postnatally 1 and 6 months postpartum nad prenatally at 35-38 week of gestation Breastfeeding outcomes assessment: 1 and 6 months postpartum)
- Correlation Between Stressful Life Events (Holmes and Rahe Stress Scale) and Breastfeeding Success(Assessment of stressful life events: During pregnancy for the last year . Breastfeeding outcomes assessment: 1 and 6 months postpartum)
研究者
Aikaterini Fotiou
MD, MSc, Pediatrician -Neonatologist, Director of Neonatal Dept/NICU, General and Maternity Hospital "Helena Venizelou", Athens, Greece
National and Kapodistrian University of Athens