Reducing Preterm Births in Underserved Pregnant Women

Study Overview
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Brief Summary
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Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex. If the proposed system proves to be effective in reducing preterm births it can improve maternal and child quality of life as well as reduce the economic burden of preterm births in the U.S.

Detailed Description
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The primary aim of this proposal is to test the efficacy of a clinic-based, computer-assisted intervention system to significantly reduce preterm births in high-risk populations. This system will: (1) assess a pregnant woman's unique risks in six modifiable areas associated with increased risks of preterm birth including smoking cessation, poor nutrition, domestic violence, maternal depression and stress, urinary and reproductive tract infections and substance use; (2) provide her with tailored advice and action planning tools on reducing her risks; (3) provide her certified nurse midwife or physician with information related to her assessed risks and counseling suggestions tailored for her needs, and [(4) promote effective referrals to, and successful linkages with community-based support organizations.] Because preterm birth rates are much higher for underserved African American women, we are proposing to focus the intervention with this population.

Official Title
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Reducing Preterm Births in Underserved Pregnant Women

Conditions
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Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams

Intervention / Treatment
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* Behavioral: lifestyle support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study inclusion criteria include: age 16-48 years, 1st trimester of pregnancy, race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher. Exclusion Criteria: Exclusion criteria include: a medical condition or risk to the pregnancy that the physician or nurse midwife determines serious and a reason for exclusion, and a literacy level of < grade 6. No prior experience using a computer is needed. -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual clinical care<br>usual clinical care with no intervention | |
| Experimental: lifestyle counseling<br>computer-based clinical support to patient | Behavioral: lifestyle support<br>* computer-based lifestyle improvement support and clinician support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight | Birth weight < 2500 grams | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Weight |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computer-based behavioral support