Nurse Family Partnership for mothers with previous live births
Trial of Nurse Family Partnership for Women With Previous Live Births
This study is testing whether the Nurse Family Partnership program can help mothers who have had previous live births have healthier pregnancies and better outcomes for their children compared to regular community services.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 16 Years to 46 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05887115 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Nurse Family Partnership (NFP) program for mothers who have had previous live births. The study will recruit 500 multiparous women who are pregnant at 32 weeks gestational age or less, comparing those receiving NFP services to those receiving standard community services. The primary goals include reducing maternal morbidity and improving pregnancy outcomes, as well as enhancing child development outcomes for their index children. Additionally, the study will explore the impact of NFP on younger siblings living in the home.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with a history of previous live births who are at least 32 weeks gestational age and meet specific risk criteria.
Not a fit: Patients who are not eligible include those already enrolled in a home-visiting program or those unable to provide informed consent.
Why it matters
Potential benefit: If successful, this program could significantly improve maternal and child health outcomes for high-risk families.
How similar studies have performed: Previous studies of the Nurse Family Partnership have shown positive outcomes, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. pregnant at 32 weeks EGA or less 2. history of previous live birth 3. covered by Medicaid or Medicaid-eligible 4. at least one of the following risks or adversities -age 19 or younger, no high school degree or equivalent, homeless (using a standardized definition), previous birth with low birth weight or prematurity, previous pregnancy with severe morbidity based on Centers for Disease Control definition, current pregnancy within 18 months of previous pregnancy, currently using tobacco or marijuana, history of substance use disorder, and self-identification as Black/African American (as a marker of facing the adversity of structural racism). Exclusion Criteria: 1. unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish 2. are already enrolled in a home-visiting intervention with this pregnancy 3. have previously been enrolled in NFP 4. under the age of 16 years. Note that we propose to exclude those who don't speak English or Spanish from our study because the community served by the two NFP delivery sites participating in our study is mostly English-speaking with some Spanish-speaking. However, those who don't speak English or Spanish are not excluded from participation in NFP, and NFP routinely provides services to all eligible families regardless of language spoken using bilingual/multilingual nurses when available or using interpretation services. NFP materials for nurses to use with families, known as 'facilitators', are available in several languages. In the rare circumstance that a pregnant woman is excluded from participating in our study based on language, they will not be excluded from receiving NFP.
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Mandy A Allison, MD, MSPH — University of Colorado School of Medicine
- Study coordinator: Natalie J Murphy
- Email: natalie.murphy@cuanschutz.edu
- Phone: 7206722402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.