MedPath

Reducing Preterm Births in Underserved Pregnant Women

Phase 2
Completed
Conditions
Verylow Birthweight <1500 Grams
Preterm Birth
Low Birth Weight <2500 Grams
Interventions
Behavioral: lifestyle support
Registration Number
NCT01344616
Lead Sponsor
PHCC LP
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
482
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. -

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
lifestyle counselinglifestyle supportcomputer-based clinical support to patient
Primary Outcome Measures
NameTimeMethod
Birthweight9 months

Birth weight \< 2500 grams

Secondary Outcome Measures
NameTimeMethod
Gestational Weight9 months

Trial Locations

Locations (1)

PHCC LP

🇺🇸

Pueblo, Colorado, United States

PHCC LP
🇺🇸Pueblo, Colorado, United States
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