Bridging mothers with their children

ISRCTN	ISRCTN16797101
DOI	https://doi.org/10.1186/ISRCTN16797101
APVV	18-0283
Sponsor	The Slovak Research and Development Agency
Funder	Biomedical Research Center of the SAS, The Slovak Research and Development Agency

Submission date: 24/02/2026
Registration date: 26/02/2026
Last edited: 26/02/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Daniela Jezova
Principal investigator, Scientific, Public

Laboratory of psycho-neuropharmacology
Institute of Experimental Endocrinology
Biomedical Research Center of the SAS
Dúbravská cesta 9
Bratislava
84505
Slovakia

ORCID ID	0000-0003-1932-2950
Phone	+421 232295215
Email	daniela.jezova@savba.sk

Study information

Primary study design	Observational
Observational study design	Cohort study
Participant information sheet	49085 Patient_Information_EN2.pdf
Scientific title	Bridging maternal and child psychological and neuroendocrine functions: underlying mechanisms
Study objectives
Ethics approval(s)	Approved 28/11/2019, Ethics Committee of the University Hospital with Polyclinic Bratislava (St. Cyril and Methodius Hospital, Antolska 11, Bratislava, 85107, Slovakia; +421 268672507; stefan.simko@pe.unb.sk), ref: 11282019
Health condition(s) or problem(s) studied	The study focuses on the relationship between maternal and child psychological states, with a focus on postpartum blues and the mechanisms that play a key role in mediating this connection.
Intervention	The dyads (mothers and simultaneously their neonates) are being investigated twice, namely 3–4 days (72–96 h) postpartum and 7–9 months postpartum. The first examinations are done at the maternity hospital on the day of the discharge in the afternoon (13.00–16.00 h) to avoid the influence of daily rhythms on endocrine parameters. The mothers are administered psychometric questionnaires (EPDS, BDI, STAI, CISS, ZUNG). Saliva samples are collected from both the mother and her neonate under resting, non-stress conditions as well as in response to compulsory heel blood sampling in the form of the heel-prick test and in response to Still face test Paradigm. A 3 cm long strip of hair (starting from the scalp) is obtained from the mother at the time of both visits.
Intervention type	Mixed
Primary outcome measure(s)	Maternal depressive symptoms measured using Edinburgh Postnatal Depression Scale EPDS, STAI, BDI, ZUNG, CISS at 3rd or 4th post partum day, at 7th - 9th months of infant age Mother and infant salivary cortisol and alfa-amylase reactivity measured using ELISA, kinetic enzyme assay at sampling in the afternoon (13.00–16.00h ), before stressor application and 20 minutes after Hair cortisol measured using ELISA at in the end testing at 3rd or 4th post partum day, at the 7–9 month postpartum, in the end of a follow-up visit at the Research Clinic
Key secondary outcome measure(s)	FACS Facial action unit activity measured using automated computational analysis at during Still face test
Completion date	30/08/2030

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	3 Days
Upper age limit	45 Years
Sex	All
Target sample size at registration	84
Total final enrolment	84
Key inclusion criteria	1. A physiological course of gravidity, term birth (37 weeks 0 days to 41 weeks 6 days of gestation), 2. Eutrophic neonate with good post-delivery adaptation (Apgar score 7 or more in the first minute, pH in umbilical cord blood above 7.2)
Key exclusion criteria	1. The chronic somatic diseases of the mother before or during gravidity 2. A psychiatric disorder of the mother 3. Occurrence of gestosis, gestational diabetes or liver disease in pregnancy 4. BMI above 30 kg/m² at the beginning of pregnancy 5. Surgical conductance of the labor (forceps, vacuum extractor) 6. Drug abuse 7. Asphyxia of the neonate (Apgar score <6 in the 5th minute and/or pH in umbilical cord blood in the first minute below 7.2)
Date of first enrolment	01/11/2020
Date of final enrolment	06/02/2024

Locations

Countries of recruitment

Slovakia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date added	Peer reviewed?	Patient-facing?
Other files	Informed consent	26/02/2026	No	No
Other files	Informed consent in Slovak	26/02/2026	No	No
Participant information sheet		26/02/2026	No	Yes
Participant information sheet	in Slovak	26/02/2026	No	Yes
Protocol file		26/02/2026	No	No

Additional files

49085 Protocol studie_template_who_Neverbalne.pdf: Protocol file
49085 Patient_Information_SK.pdf: in Slovak
49085 Patient_Information_EN2.pdf: Participant information sheet
49085 Informovany_suhlas.pdf: Informed consent in Slovak
49085 Informed_Consent_EN2.pdf: Informed consent

Editorial Notes

24/02/2026: Trial's existence confirmed by Ethics Committee of the University Hospital with Polyclinic Bratislava.