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Reducing Preterm Births in Underserved Pregnant Women

NCT ID: NCT01344616

Last Updated: 2014-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

482 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-10-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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usual clinical care

usual clinical care with no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

lifestyle counseling

computer-based clinical support to patient

Group Type EXPERIMENTAL

lifestyle support

Intervention Type BEHAVIORAL

computer-based lifestyle improvement support and clinician support

Interventions

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lifestyle support

computer-based lifestyle improvement support and clinician support

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. age 16-48 years,
2. 1st trimester of pregnancy,
3. race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher.

Exclusion Criteria

1. a medical condition or risk to the pregnancy that the physician or nurse midwife determines serious and a reason for exclusion, and
2. a literacy level of \< grade 6. No prior experience using a computer is needed. -
Minimum Eligible Age

16 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PHCC LP

INDUSTRY

Sponsor Role lead

Responsible Party

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James G. Christian

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PHCC LP

Pueblo, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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2R44HD047031-02A2

Identifier Type: NIH

Identifier Source: org_study_id

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