CompletedNot Applicable

Breastfeeding, Early Prenatal Stress Intervention, and Infant Neurodevelopment

Greece162 participantsStarted 2018-02-01

Plain-language 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?

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prenatal Breastfeeding Self-Efficacy Across Study Groups

Timeframe: 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

Timeframe: At 1 and 6 months postpartum

Breastfeeding Outcomes Across Study Groups

Timeframe: at 1 and 6 Months Postpartum

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

Timeframe: 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

Timeframe: 4-7 days postpartum

Infant Behavioral Assessment Across Study Groups

Timeframe: IBQ-R SF will be measured at 6 months postpartum

Trial details

NCT IDNCT06876051

SponsorNational and Kapodistrian University of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

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