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Nurse Family Partnership for Pregnancies

N/A

Recruiting

Led By Mandy A Allison, MD, MSPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the effectiveness of the Nurse Family Partnership (NFP) in mothers with previous live births to reduce maternal morbidity & improve pregnancy & child outcomes, & describe & evaluate the effects of NFP on prior-born siblings.

Who is the study for?

This trial is for pregnant women who are less than 28 weeks along, have had a previous live birth, and qualify for Medicaid. They must also meet one of these conditions: under 20 years old, no high school diploma, homeless, past low-weight or premature births, severe pregnancy complications before, got pregnant within 18 months after last pregnancy, use tobacco or marijuana currently or have a history of substance abuse.

What is being tested?

The Nurse Family Partnership program is being tested to see if it helps reduce health problems in mothers with more than one child and improves the outcomes for their new baby as well as older siblings under six. The program involves home visits from nurses to provide support.

What are the potential side effects?

Since this intervention involves nurse home visits rather than medication or medical procedures, there aren't typical side effects like you'd expect with drugs. However, participants may experience emotional impacts due to discussions about personal topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in maternal tobacco use by cotinine

Change in self reported maternal tobacco use

DNA methylation biomarkers

+3 more

Secondary study objectives

Change in maternal perceived stress measured by Perceived Stress Scale (maternal report)

Change in quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale

Change in quality of home environment measured by the HOME (Home Observation Measurement of the Environment) Inventory short form

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Intervention (NFP)Active Control1 Intervention

In the standard NFP intervention, low-income pregnant women are recruited to voluntarily join the program through their 28th week of pregnancy. Enrolled women receive home visits from a nurse. The visits can occur in-person or via telehealth. In-person visits can occur in the client's home or in another community location agreed upon by the client and the nurse (such as a library or coffee shop). The typical schedule for visits is weekly during the first month after enrollment, every two weeks until the birth of the infant, weekly during the post-partum period, then every two to four weeks until child age two.

Group II: ControlActive Control1 Intervention

The control group will receive usual care for pregnant people, which may include home visiting services from another source other than NFP. Participants who are randomly selected to receive other services will be given information about other services for which they may qualify and information about how to access those services.

Do I qualify?Apply below to find out