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NCT04821544
Maternal Stress on Human Milk and Infant Outcomes
NA trial testing Mindfulness-based intervention (with a focus on self-compassion; MBSC) in Postpartum Depression in 500 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | University of Idaho |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 500 |
| Start date | 1 May 2021 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mindfulness-based intervention (with a focus on self-compassion; MBSC)
- Vitamin D
Conditions studied
- Postpartum Depression — all drugs for Postpartum Depression →
- Preterm Labor — all drugs for Preterm Labor →
Sponsor
University of Idaho
Who can join
Adults 18 to 50, female only, with Postpartum Depression or Preterm Labor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04821544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Postpartum Depression
Currently open trials in the same condition.
- NCT07398469 — A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone · recruiting
- NCT06442774 — MamaConecta: Digital Tool for Maternal Mental Health · NA · recruiting
- NCT06545760 — Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression · NA · recruiting
- NCT05763537 — Understanding the Role of Doulas in Supporting People With PMADs · NA · recruiting
- NCT06462638 — COntact RElationship in Neonatal Intensive Care Unit · recruiting
Other University of Idaho trials
Trials by the same sponsor.
- NCT06919718 — Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho · NA · recruiting
- NCT06721468 — Trout Consumption in Young Children and Families and Brain Health · NA · recruiting
- NCT05951491 — Improving Arm Function Using Wearable Exoskeletons · NA · unknown
- NCT05986539 — Early Life Feeding Exposure and Infant Immune and Health Status. · recruiting
- NCT05619445 — Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04821544 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Idaho
- Last refreshed: 18 May 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/NCT04821544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing