NCT06876051 (PRIMAS-BIN) is a NA clinical trial of Relaxation & Breastfeeding Education in Stress, sponsored by National and Kapodistrian University of Athens.

Who is sponsoring NCT06876051?

NCT06876051 is sponsored by National and Kapodistrian University of Athens.

What drugs are being tested in NCT06876051?

Interventions in NCT06876051: Relaxation & Breastfeeding Education, Active comparator, control group.

What condition does NCT06876051 study?

NCT06876051 studies Stress, Relaxation, Breastfeeding, Infant Behavior, Prenatal Stress.

Is NCT06876051 still recruiting?

NCT06876051 is currently completed. Last updated 14 March 2025.

Last reviewed 2025-03-14 · How we verify

NCT06876051: PRIMAS-BIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prenatal Intervention of Maternal Stress - Breastfeeding & Infant Neurodevelopment

Completed NA Last updated 14 March 2025

What this trial tests

NA trial testing Relaxation & Breastfeeding Education in Stress in 162 participants. Completed in 10 September 2024.

Timeline

1 February 2018

Primary endpoint
15 December 2023

10 September 2024

Quick facts

Lead sponsor	National and Kapodistrian University of Athens
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	162
Start date	1 February 2018
Primary completion	15 December 2023
Estimated completion	10 September 2024
Sites	1 location across Greece

Drugs / interventions tested

Relaxation & Breastfeeding Education
Active comparator — full drug profile →
control group — full drug profile →

Conditions studied

Stress — all drugs for Stress →
Relaxation — all drugs for Relaxation →
Breastfeeding — all drugs for Breastfeeding →
Infant Behavior — all drugs for Infant Behavior →

Sponsor

National and Kapodistrian University of Athens

Who can join

18 and older, female only, with Stress or Relaxation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Greek validation of the Pregnancy Experience Scale-Brief (PES-Brief): psychometric evaluation of prenatal stress in pregnant women.
Fotiou A, Parastatidou S, Pervanidou P, Chrousos GP, et al · · 2026 · PMID 41645128 · DOI 10.1186/s12884-026-08740-y

Verify or expand the search:

Other recruiting trials for Stress

Currently open trials in the same condition.

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Other National and Kapodistrian University of Athens trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06876051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National and Kapodistrian University of Athens
Last refreshed: 14 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06876051.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing