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NCT04438031 · ClinicalTrials.gov registry record · NA
Navigation Study: Durham
A NA study of Prenatal; Postnatal, sponsored by Duke University.
- Active
- Registry status
- NA
- Development phase
- 815
- Enrollment target
- 1
- Study location
NCT04438031: Active NA study of Prenatal; Postnatal, sponsored by Duke University.
NCT04438031 is a NA study of Prenatal; Postnatal that is active but no longer recruiting, run by Duke University. The registered enrollment target is 815 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04438031, a NA study of Prenatal; Postnatal, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 815 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Proportion of participants in the Navigation group who agree to schedule a prenatal Navigation visit, which will be collected from enrollment logs.
Conditions Studied
Interventions
- BEHAVIORAL Control Intervention
- BEHAVIORAL Navigation Intervention Prenatal 1.0 (intervention discontinued, modified to 2.0. Data will not be used)
- BEHAVIORAL Navigation Intervention Prenatal 2.0
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 815 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2030-06-30 |
| Phase | NA |
What the registry record for NCT04438031 still lists
NCT04438031 is an interventional study that assigns participants to a tested intervention. The registered 815 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Prenatal; Postnatal appearing as the primary indexed condition, and to 3 interventions - of which Control Intervention is the first listed.
NCT04438031 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04438031 about?
NCT04438031 is a clinical study titled "Navigation Study: Durham". 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, ...
What is the current status of trial NCT04438031?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 815 participants. The study started on 2020-11-20. Estimated completion is 2030-06-30.
What conditions does trial NCT04438031 study?
This clinical trial studies the following conditions: Prenatal; Postnatal.
What interventions are being tested in trial NCT04438031?
The interventions under investigation include: Control Intervention (BEHAVIORAL), Navigation Intervention Prenatal 1.0 (intervention discontinued, modified to 2.0. Data will not be used) (BEHAVIORAL), Navigation Intervention Prenatal 2.0 (BEHAVIORAL).
Who is sponsoring clinical trial NCT04438031?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04438031 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04438031's enrollment target sits among peer trials
815 134th of 2000 higher than 1,867 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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