Non-pharmacological interventions in stressed pregnant women - Fetal EarLy non-Invasive biomarkers of chronic maternal stress during pregnancy resulting in alterations of infant CognItive development 2

Non-pharmacological interventions in stressed pregnant women - Fetal EarLy non-Invasive biomarkers of chronic maternal stress during pregnancy resulting in alterations of infant CognItive development 2 - FELICITy2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037529

Enrollment

Registered

2025-07-24

Start date

2022-12-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress levels in stressed pregnant women

Interventions

Group 1: Intervention group (yoga group) For the intervention group, in the following named yoga group, an integral prenatal yoga program was developed in collaboration with a certified prenatal yoga

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: The screening process involved the implementation of the Cohen Perceived Stress Scale-10 (PSS-10), a standardized instrument designed to identify individuals exhibiting elevated stress levels. A cutoff score of = 19 was established, representing the 80th percentile of the PSS-10 according to Lobmaier et al., and served as the primary inclusion criterion. + Participants had to be between between 12 + 0 and 20 + 0 weeks pregnant at the time of enrollment + Singleton pregnancy + Fluency in spoken and written German + Willing to attending at least 75% of the available yoga sessions.

Exclusion criteria

Exclusion criteria: Fetal malformations or profound placental alterations Fetal genetic disorders Maternal severe illness during pregnancy (Killpatrick et al.) Preterm birth Maternal drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame
- A well-designed yoga/relaxation program for stressed pregnant women, will decrease maternal stress level (Perceived Stress Scale-10 (PSS-10) score) at delivery compared to controls OR - Fetal automatic nervous system capacity (measured by transabdominal ECG) will be different between both groups	—

Secondary

Measure	Time frame
- Yoga/relaxation program for stressed pregnant women will decrease “Prenatal distress questionnaire ” (PDQ) score compared to controls - Yoga/relaxation program for stressed pregnant women will decrease “Edinburgh Postnatal Depression Scale” (EPDS) - Combined adverse birth outcome (pH <7.15, operative delivery rate, 5 min Apgar score < 7, NICU admission) will be better in the Yoga intervention group - Maternal cortisol level (measured in hair) will be lower in the Yoga intervention group - There will be differences in the epigenetic profile between both groups - Parent Report of Children’s Abilities-Revised (PARCA-R) results at 2 years corrected age will be better in the Yoga intervention group	—

Measure

Time frame

- Yoga/relaxation program for stressed pregnant women will decrease “Prenatal distress questionnaire ” (PDQ) score compared to controls - Yoga/relaxation program for stressed pregnant women will decrease “Edinburgh Postnatal Depression Scale” (EPDS) - Combined adverse birth outcome (pH <7.15, operative delivery rate, 5 min Apgar score < 7, NICU admission) will be better in the Yoga intervention group - Maternal cortisol level (measured in hair) will be lower in the Yoga intervention group - There will be differences in the epigenetic profile between both groups - Parent Report of Children’s Abilities-Revised (PARCA-R) results at 2 years corrected age will be better in the Yoga intervention group

—

Countries

Germany

Contacts

Public ContactSilvia Lobmaier

Klinikum rechts der Isar der TU München

silvia.lobmaier@tum.de089 4140 5417

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026