Prenatal Intervention of Maternal Stress - Breastfeeding & Infant Neurodevelopment

NCT06876051 | Completed DMC

• 3 other identifiers: 1617031875 / 04-07-17ID 126/04-09-171617031875/2017
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does stress management in pregnant women using relaxation techniques increase the likelihood of exclusive breastfeeding at one and six months postpartum?
2. 2.Does it impact neonatal and infant growth and behavior?
3. 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. 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

Keywords

breastfeeding; BDNF; Reelin; pregnancy; relaxation techniques; stress management

Outcome Measures

Primary Outcomes (6)

• Prenatal Breastfeeding Self-Efficacy Across Study Groups

  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.

  1) between 15 - 20 week of gestation and 2) between 35-38 weeks gestation before child birth

• Breastfeeding Self-Efficacy across the study groups and the time frames

  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.

  At 1 and 6 months postpartum

• Breastfeeding Outcomes Across Study Groups

  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.

  at 1 and 6 Months Postpartum

• Neurotrophin Levels as Neurodevelopmental Parameters in Maternal Serum and Umbilical Cord Blood across the study groups

  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.

  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

• Neonatal Behavioral Assessment Across Study Groups

  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.

  4-7 days postpartum

• Infant Behavioral Assessment Across Study Groups

  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.

  IBQ-R SF will be measured at 6 months postpartum

Secondary Outcomes (16)

• 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

Other Outcomes (7)

• Correlation of Mother-child attachment and breastfeeding success

  At 6 months postpartum

• Correlation of Neonatal and Infant Anthropometric parameters with breastfeeding success across the study groups

  Neonatal anthropometric measurements: At birth Infant anthropometric measurements: 1 and 6 months postpartum Breastfeeding outcomes assessment: 1 and 6 months postpartum

• Correlation Between prenatal Cortisol Levels and Perceived Stress (PSS-14)

  Prenatal cortisol & PSS-14 assessment: 15-20 and 35-38 weeks of gestation. Postnatal PSS-14 assessment: 1 and 6 months postpartum

Study Arms (3)

Behavioral: Relaxation & Breastfeeding Education

EXPERIMENTAL

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.

Behavioral: Relaxation & Breastfeeding Education

Behavioral : Breastfeeding Education Alone

ACTIVE COMPARATOR

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.

Behavioral: Active comparator

Standard Maternity Care (Control Group)

OTHER

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.

Other: control group

Interventions

Relaxation & Breastfeeding Education BEHAVIORAL

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

Also known as: Prenatal relaxation techniques, prenatal stress management, prenatal educational breastfeeding programme, diaphragmatic breathing, progressive Muscle Relaxation, Guided Imagery, positive thinking

Behavioral: Relaxation & Breastfeeding Education

Active comparator BEHAVIORAL

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.

Also known as: prenatal Breastfeeding Education, Infant cues on breastfeeding, breastmilk benefits, breastfeeding guide

Behavioral : Breastfeeding Education Alone

control group OTHER

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.

Also known as: Routine Maternity Care, Baby Friendly Hospital Initiative

Standard Maternity Care (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study includes only primiparous pregnant women from the beginning of the second trimester until the end of the 36th gestational week.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparous pregnant women
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• General and Maternity Hospital of Athens Elena Venizelou: collaborator

Study Sites (1)

Maternity Hospital "ELENA VENIZELOU"

Athens, Attica, 11521, Greece

Location

Related Publications (31)

• Liang IJ. The wonders of mind-body practices during pregnancy: A topical review. Taiwan J Obstet Gynecol. 2024 Jul;63(4):486-491. doi: 10.1016/j.tjog.2024.04.007.

  PMID: 39004474 BACKGROUND

• Alshammari M, Lee RLT, Stubbs M, Chan SW. Effectiveness of psychoeducation interventions for pregnant women with gestational diabetes mellitus: an integrative review. BMC Public Health. 2024 Oct 22;24(1):2929. doi: 10.1186/s12889-024-20428-6.

  PMID: 39438847 BACKGROUND

• D'Angelo A, Ceccanti M, Petrella C, Greco A, Tirassa P, Rosso P, Ralli M, Ferraguti G, Fiore M, Messina MP. Role of neurotrophins in pregnancy, delivery and postpartum. Eur J Obstet Gynecol Reprod Biol. 2020 Apr;247:32-41. doi: 10.1016/j.ejogrb.2020.01.046. Epub 2020 Jan 30.

  PMID: 32058187 BACKGROUND

• Ardalan M, Chumak T, Quist A, Hermans E, Hoseinpoor Rafati A, Gravina G, Jabbari Shiadeh SM, Svedin P, Alabaf S, Hansen B, Wegener G, Westberg L, Mallard C. Reelin cells and sex-dependent synaptopathology in autism following postnatal immune activation. Br J Pharmacol. 2022 Sep;179(17):4400-4422. doi: 10.1111/bph.15859. Epub 2022 May 23.

  PMID: 35474185 BACKGROUND

• Fotiou C, Siahanidou T, Vlastarakos PV, Tavoulari EF, Chrousos G. The effect of body and mind stress-releasing techniques on the breastfeeding of full-term babies; a critical analysis of published interventional studies. J Matern Fetal Neonatal Med. 2018 Jan;31(1):98-105. doi: 10.1080/14767058.2016.1275547. Epub 2017 May 9.

  PMID: 28043180 BACKGROUND

• Fotiou C, Vlastarakos PV, Bakoula C, Papagaroufalis K, Bakoyannis G, Darviri C, Chrousos G. Parental stress management using relaxation techniques in a neonatal intensive care unit: A randomised controlled trial. Intensive Crit Care Nurs. 2016 Feb;32:20-8. doi: 10.1016/j.iccn.2015.08.006.

  PMID: 26520208 BACKGROUND

• Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

  PMID: 24395196 BACKGROUND

• Palacios-Garcia I, Lara-Vasquez A, Montiel JF, Diaz-Veliz GF, Sepulveda H, Utreras E, Montecino M, Gonzalez-Billault C, Aboitiz F. Prenatal stress down-regulates Reelin expression by methylation of its promoter and induces adult behavioral impairments in rats. PLoS One. 2015 Feb 13;10(2):e0117680. doi: 10.1371/journal.pone.0117680. eCollection 2015.

  PMID: 25679528 BACKGROUND

• Hirota Y, Nakajima K. Control of Neuronal Migration and Aggregation by Reelin Signaling in the Developing Cerebral Cortex. Front Cell Dev Biol. 2017 Apr 26;5:40. doi: 10.3389/fcell.2017.00040. eCollection 2017.

  PMID: 28507985 BACKGROUND

• Ranaivoson FM, von Daake S, Comoletti D. Structural Insights into Reelin Function: Present and Future. Front Cell Neurosci. 2016 May 27;10:137. doi: 10.3389/fncel.2016.00137. eCollection 2016.

  PMID: 27303268 BACKGROUND

• Boersma GJ, Lee RS, Cordner ZA, Ewald ER, Purcell RH, Moghadam AA, Tamashiro KL. Prenatal stress decreases Bdnf expression and increases methylation of Bdnf exon IV in rats. Epigenetics. 2014 Mar;9(3):437-47. doi: 10.4161/epi.27558. Epub 2013 Dec 23.

  PMID: 24365909 BACKGROUND

• Taliaz D, Stall N, Dar DE, Zangen A. Knockdown of brain-derived neurotrophic factor in specific brain sites precipitates behaviors associated with depression and reduces neurogenesis. Mol Psychiatry. 2010 Jan;15(1):80-92. doi: 10.1038/mp.2009.67. Epub 2009 Jul 21.

  PMID: 19621014 BACKGROUND

• Malamitsi-Puchner A, Economou E, Rigopoulou O, Boutsikou T. Perinatal changes of brain-derived neurotrophic factor in pre- and fullterm neonates. Early Hum Dev. 2004 Jan;76(1):17-22. doi: 10.1016/j.earlhumdev.2003.10.002.

  PMID: 14729159 BACKGROUND

• Claes S. Neuroepigenetics of Prenatal Psychological Stress. Prog Mol Biol Transl Sci. 2018;158:83-104. doi: 10.1016/bs.pmbts.2018.04.007. Epub 2018 Jun 6.

  PMID: 30072061 BACKGROUND

• Daskalakis NP, De Kloet ER, Yehuda R, Malaspina D, Kranz TM. Early Life Stress Effects on Glucocorticoid-BDNF Interplay in the Hippocampus. Front Mol Neurosci. 2015 Nov 16;8:68. doi: 10.3389/fnmol.2015.00068. eCollection 2015.

  PMID: 26635521 BACKGROUND

• Guan SZ, Fu YJ, Zhao F, Liu HY, Chen XH, Qi FQ, Liu ZH, Ng TB. The mechanism of enriched environment repairing the learning and memory impairment in offspring of prenatal stress by regulating the expression of activity-regulated cytoskeletal-associated and insulin-like growth factor-2 in hippocampus. Environ Health Prev Med. 2021 Jan 15;26(1):8. doi: 10.1186/s12199-020-00929-7.

  PMID: 33451279 BACKGROUND

• Guan SZ, Ning L, Tao N, Lian YL, Liu JW, Ng TB. Effects of maternal stress during pregnancy on learning and memory via hippocampal BDNF, Arc (Arg3.1) expression in offspring. Environ Toxicol Pharmacol. 2016 Sep;46:158-167. doi: 10.1016/j.etap.2016.04.012. Epub 2016 Jun 29.

  PMID: 27474832 BACKGROUND

• Conradt E, Adkins DE, Crowell SE, Raby KL, Diamond LM, Ellis B. Incorporating epigenetic mechanisms to advance fetal programming theories. Dev Psychopathol. 2018 Aug;30(3):807-824. doi: 10.1017/S0954579418000469.

  PMID: 30068415 BACKGROUND

• Sandman CA, Davis EP, Buss C, Glynn LM. Exposure to prenatal psychobiological stress exerts programming influences on the mother and her fetus. Neuroendocrinology. 2012;95(1):7-21. doi: 10.1159/000327017. Epub 2011 Apr 15.

  PMID: 21494029 BACKGROUND

• Creutzberg KC, Sanson A, Viola TW, Marchisella F, Begni V, Grassi-Oliveira R, Riva MA. Long-lasting effects of prenatal stress on HPA axis and inflammation: A systematic review and multilevel meta-analysis in rodent studies. Neurosci Biobehav Rev. 2021 Aug;127:270-283. doi: 10.1016/j.neubiorev.2021.04.032. Epub 2021 May 2.

  PMID: 33951412 BACKGROUND

• Grundwald NJ, Brunton PJ. Prenatal stress programs neuroendocrine stress responses and affective behaviors in second generation rats in a sex-dependent manner. Psychoneuroendocrinology. 2015 Dec;62:204-16. doi: 10.1016/j.psyneuen.2015.08.010. Epub 2015 Aug 17.

  PMID: 26318631 BACKGROUND

• Hernandez-Reif M, Kendrick A, Avery DM. Pregnant women with depressive and anxiety symptoms read, talk, and sing less to their fetuses. J Affect Disord. 2018 Mar 15;229:532-537. doi: 10.1016/j.jad.2017.12.108. Epub 2018 Jan 5. No abstract available.

  PMID: 29353212 BACKGROUND

• Vega-Sanz M, Rey-Saez R, Berastegui A, Sanchez-Lopez A. Difficulties in Pregnancy Adjustment as Predictors of Perinatal Depression: Indirect Effects through the Role of Brooding Rumination and Maternal-Fetal Bonding. Am J Perinatol. 2024 May;41(S 01):e2870-e2877. doi: 10.1055/s-0043-1776062. Epub 2023 Oct 17.

  PMID: 37848044 BACKGROUND

• Witt WP, Litzelman K, Cheng ER, Wakeel F, Barker ES. Measuring stress before and during pregnancy: a review of population-based studies of obstetric outcomes. Matern Child Health J. 2014 Jan;18(1):52-63. doi: 10.1007/s10995-013-1233-x.

  PMID: 23447085 BACKGROUND

• Lau C. Effects of stress on lactation. Pediatr Clin North Am. 2001 Feb;48(1):221-34. doi: 10.1016/s0031-3955(05)70296-0. No abstract available.

  PMID: 11236728 BACKGROUND

• Tavoulari EF, Benetou V, Vlastarakos PV, Psaltopoulou T, Chrousos G, Kreatsas G, Gryparis A, Linos A. Factors affecting breastfeeding duration in Greece: What is important? World J Clin Pediatr. 2016 Aug 8;5(3):349-57. doi: 10.5409/wjcp.v5.i3.349. eCollection 2016 Aug 8.

  PMID: 27610353 BACKGROUND

• Atchan M, Davis D, Foureur M. The impact of the Baby Friendly Health Initiative in the Australian health care system: a critical narrative review of the evidence. Breastfeed Rev. 2013 Jul;21(2):15-22.

  PMID: 23957177 BACKGROUND

• Skouteris H, Bailey C, Nagle C, Hauck Y, Bruce L, Morris H. Interventions Designed to Promote Exclusive Breastfeeding in High-Income Countries: A Systematic Review Update. Breastfeed Med. 2017 Dec;12(10):604-614. doi: 10.1089/bfm.2017.0065. Epub 2017 Sep 8.

  PMID: 28885859 BACKGROUND

• Bartick MC, Schwarz EB, Green BD, Jegier BJ, Reinhold AG, Colaizy TT, Bogen DL, Schaefer AJ, Stuebe AM. Suboptimal breastfeeding in the United States: Maternal and pediatric health outcomes and costs. Matern Child Nutr. 2017 Jan;13(1):e12366. doi: 10.1111/mcn.12366. Epub 2016 Sep 19.

  PMID: 27647492 BACKGROUND

• Mimouni FB, Koletzko B. Human Milk for Preterm Infants. Clin Perinatol. 2017 Mar;44(1):xix-xx. doi: 10.1016/j.clp.2016.12.001. No abstract available.

  PMID: 28159213 BACKGROUND

• Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.

  PMID: 23178060 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Infant Behavior

Interventions

Autogenic Training; Imagery, Psychotherapy; Control Groups

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  STUDY DIRECTOR

• Aikaterini Fotiou, MD, MSc

  Neonatal Dept_Maternity Hosp_Elena Venizelou_2_Plateia Elenas Venizelou Str_Athens 115 21_GR

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Pediatrician -Neonatologist, Director of Neonatal Dept/NICU, General and Maternity Hospital "Helena Venizelou", Athens, Greece

Model Details: Primipara Pregnant women are randomly assigned to one of three groups: (1) an intervention group receiving relaxation techniques combined with breastfeeding education, (2) an active control group receiving only breastfeeding education, and (3) a control group receiving standard maternity care.

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: March 14, 2025
• Study Start: February 1, 2018
• Primary Completion: December 15, 2023
• Study Completion: September 10, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)