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NCT03360539 · ClinicalTrials.gov registry record · NA
Nurse-Family Partnership Impact Evaluation in South Carolina
A NA study of Preterm Birth and Maternal Behavior, sponsored by Harvard School of Public Health (HSPH).
- Active
- Registry status
- NA
- Development phase
- 5,670
- Enrollment target
- 9
- Study locations
NCT03360539: Active NA study of Preterm Birth and Maternal Behavior, sponsored by Harvard School of Public Health (HSPH).
NCT03360539 is a NA study of Preterm Birth and Maternal Behavior that is active but no longer recruiting, run by Harvard School of Public Health (HSPH). The registered enrollment target is 5,670 participants, above the 4,264-participant average among 39 other Preterm Birth trials with a reported enrollment target (33% higher). The trial reports 9 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03360539, a NA study of Preterm Birth and Maternal Behavior, is active but no longer recruiting, sponsored by Harvard School of Public Health (HSPH).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 5,670 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.
Primary Outcome
Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life).
Conditions Studied
Interventions
- BEHAVIORAL Nurse-Family Partnership
Study Locations (9)
South Carolina
- Nurse-Family Partnership of Anderson County - Anderson
- NFP of Berkeley/Charleston/Dorchester Counties - Charleston
- Nurse-Family Partnership of Lexington-Richland Co. - Columbia
- Nurse-Family Partnership of Horry County - Conway
- McLeod Health NFP - Florence
- Nurse-Family Partnership of Greenville County - Greenville
- Carolina Health Centers NFP - Greenwood
- Family Solutions of the Lowcountry NFP - Orangeburg
- Spartanburg Regional Hospital NFP - Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,670 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2046-04-01 |
| Phase | NA |
What the registry record for NCT03360539 still lists
NCT03360539 is an interventional study that assigns participants to a tested intervention. Its 5,670 participants enrollment target places it among the larger protocols in the corpus, above the 4,264-participant average among 39 other Preterm Birth trials with a reported enrollment target (33% higher).
The record links to 3 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Nurse-Family Partnership is the first listed.
NCT03360539 lists 9 locations in 1 state (South Carolina).
Frequently Asked Questions
What is clinical trial NCT03360539 about?
NCT03360539 is a clinical study titled "Nurse-Family Partnership Impact Evaluation in South Carolina". This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contrac...
What is the current status of trial NCT03360539?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 5,670 participants. The study started on 2016-04-01. Estimated completion is 2046-04-01.
What conditions does trial NCT03360539 study?
This clinical trial studies the following conditions: Preterm Birth, Maternal Behavior, Injuries.
What interventions are being tested in trial NCT03360539?
The interventions under investigation include: Nurse-Family Partnership (BEHAVIORAL).
Who is sponsoring clinical trial NCT03360539?
This trial is sponsored by Harvard School of Public Health (HSPH), which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03360539 being conducted?
This trial has 9 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03360539's enrollment target sits among peer trials
5,670 6th of 39 higher than 34 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth 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.
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