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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

Tracking Information
First Submitted Date  ICMJE July 27, 2010
First Posted Date  ICMJE April 29, 2011
Results First Submitted Date  ICMJE November 10, 2014
Results First Posted Date  ICMJE November 24, 2014
Last Update Posted Date November 24, 2014
Study Start Date  ICMJE August 2010
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
Birthweight [ Time Frame: 9 months ]
Birth weight < 2500 grams
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
length of gestation [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
Gestational Weight [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Preterm Births in Underserved Pregnant Women
Official Title  ICMJE Reducing Preterm Births in Underserved Pregnant Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Preterm Birth
  • Low Birth Weight <2500 Grams
  • Verylow Birthweight <1500 Grams
Intervention  ICMJE Behavioral: lifestyle support
computer-based lifestyle improvement support and clinician support
Study Arms  ICMJE
  • No Intervention: usual clinical care
    usual clinical care with no intervention
  • Experimental: lifestyle counseling
    computer-based clinical support to patient
    Intervention: Behavioral: lifestyle support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
482
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
452
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 48 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01344616
Other Study ID Numbers  ICMJE 2R44HD047031-02A2( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James G. Christian, PHCC LP
Study Sponsor  ICMJE PHCC LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PHCC LP
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP