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Clinical Trials/NCT01344616
NCT01344616
Completed
Phase 2

Reducing Preterm Births in Underserved Pregnant Women

PHCC LP1 site in 1 country482 target enrollmentAugust 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
PHCC LP
Enrollment
482
Locations
1
Primary Endpoint
Birthweight
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
PHCC LP
Responsible Party
Principal Investigator
Principal Investigator

James G. Christian

President

PHCC LP

Eligibility Criteria

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
  • No prior experience using a computer is needed. -

Outcomes

Primary Outcomes

Birthweight

Time Frame: 9 months

Birth weight \< 2500 grams

Secondary Outcomes

  • Gestational Weight(9 months)

Study Sites (1)

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