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NCT04438031
Navigation Study: Durham
NA trial testing Navigation Intervention Prenatal 1.0 (intervention discontinued, modified to 2.0. Data will not be used) in Prenatal; Postnatal in 815 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2030
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 815 |
| Start date | 20 November 2020 |
| Primary completion | 30 June 2030 |
| Estimated completion | 30 June 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Navigation Intervention Prenatal 1.0 (intervention discontinued, modified to 2.0. Data will not be used)
- Control Intervention — full drug profile →
- Navigation Intervention Prenatal 2.0
Conditions studied
- Prenatal; Postnatal — all drugs for Prenatal; Postnatal →
Sponsor
Duke University
Who can join
0 and older, any sex, with Prenatal; Postnatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the proposed study is to evaluate the implementation and impact of a new, community-wide prevention program, "Navigation", on maternal and infant health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office and provides up to several visits (prenatally, 12 months, 24 months, and 36 months) to assess family needs, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04438031
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT04438031 (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 Duke University
- Last refreshed: 13 June 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/NCT04438031.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing