Reducing Preterm Births in Underserved Pregnant Women

PHCC LP

Status and phase: Completed; Phase 2

Conditions: Verylow Birthweight <1500 Grams; Low Birth Weight <2500 Grams; Preterm Birth

Treatments: Behavioral: lifestyle support

Study type: Interventional

Funder types: Industry

Identifiers

NCT01344616

2R44HD047031-02A2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 482 patients

Sex: Female

Ages: 16 to 48 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Study inclusion criteria include:

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: Exclusion criteria include:

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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482 participants in 2 patient groups

usual clinical care

No Intervention group

Description:

usual clinical care with no intervention

lifestyle counseling

Experimental group

Description:

computer-based clinical support to patient

Treatment:

Behavioral: lifestyle support