- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344616
Reducing Preterm Births in Underserved Pregnant Women
November 19, 2014 updated by: James G. Christian, PHCC LP
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
482
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Pueblo, Colorado, United States, 81003
- PHCC LP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: usual clinical care
usual clinical care with no intervention
|
|
Experimental: lifestyle counseling
computer-based clinical support to patient
|
computer-based lifestyle improvement support and clinician support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birthweight
Time Frame: 9 months
|
Birth weight < 2500 grams
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gestational Weight
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
July 27, 2010
First Submitted That Met QC Criteria
April 28, 2011
First Posted (Estimate)
April 29, 2011
Study Record Updates
Last Update Posted (Estimate)
November 24, 2014
Last Update Submitted That Met QC Criteria
November 19, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R44HD047031-02A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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