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Reducing Preterm Births in Underserved Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01344616
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
James G. Christian, PHCC LP

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preterm Birth Low Birth Weight <2500 Grams Verylow Birthweight <1500 Grams Behavioral: lifestyle support Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Preterm Births in Underserved Pregnant Women
Study Start Date : August 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arms and Interventions
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Arm Intervention/treatment
No Intervention: usual clinical care
usual clinical care with no intervention
Experimental: lifestyle counseling
computer-based clinical support to patient
 Behavioral: lifestyle support
computer-based lifestyle improvement support and clinician support


Outcome Measures
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Primary Outcome Measures :
  1. Birthweight [ Time Frame: 9 months ]
    Birth weight < 2500 grams


Secondary Outcome Measures :
  1. Gestational Weight [ Time Frame: 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 48 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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. -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344616


Locations
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United States, Colorado
PHCC LP
Pueblo, Colorado, United States, 81003
Sponsors and Collaborators
PHCC LP
More Information
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Responsible Party: James G. Christian, President, PHCC LP
ClinicalTrials.gov Identifier: NCT01344616    
Other Study ID Numbers: 2R44HD047031-02A2 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2011    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014
Last Verified: November 2014
Keywords provided by James G. Christian, PHCC LP:
computer-based behavioral support
Additional relevant MeSH terms:
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Premature Birth
Birth Weight
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Body Weight