Reducing Preterm Births in Underserved Pregnant Women
Primary Purpose
Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lifestyle support
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth focused on measuring computer-based behavioral support
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 6. No prior experience using a computer is needed. -
Sites / Locations
- PHCC LP
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
usual clinical care
lifestyle counseling
Arm Description
usual clinical care with no intervention
computer-based clinical support to patient
Outcomes
Primary Outcome Measures
Birthweight
Birth weight < 2500 grams
Secondary Outcome Measures
Gestational Weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01344616
Brief Title
Reducing Preterm Births in Underserved Pregnant Women
Official Title
Reducing Preterm Births in Underserved Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
PHCC LP
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
Keywords
computer-based behavioral support
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
482 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual clinical care
Arm Type
No Intervention
Arm Description
usual clinical care with no intervention
Arm Title
lifestyle counseling
Arm Type
Experimental
Arm Description
computer-based clinical support to patient
Intervention Type
Behavioral
Intervention Name(s)
lifestyle support
Intervention Description
computer-based lifestyle improvement support and clinician support
Primary Outcome Measure Information:
Title
Birthweight
Description
Birth weight < 2500 grams
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Gestational Weight
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 6. No prior experience using a computer is needed. -
Facility Information:
Facility Name
PHCC LP
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing Preterm Births in Underserved Pregnant Women
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