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OpenTrials
Completed

NCT Number: NCT01344616

Reducing Preterm Births in Underserved Pregnant Women

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.

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Key information

Age range

16 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

PHCC LP

Pueblo, Colorado, 81003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

lifestyle support

Behavioral

computer-based lifestyle improvement support and clinician support

Primary outcomes

  1. Birthweight

    Time frame: 9 months

    Birth weight < 2500 grams

Secondary outcomes

  1. Gestational Weight

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

PHCC LP

Industry

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2011
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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