Reducing Preterm Births in Underserved Pregnant Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James G. Christian, PHCC LP
ClinicalTrials.gov Identifier:
NCT01344616
First received: July 27, 2010
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Preterm Birth
Low Birth Weight <2500 Grams
Verylow Birthweight <1500 Grams
Behavioral: lifestyle support
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Preterm Births in Underserved Pregnant Women

Resource links provided by NLM:


Further study details as provided by PHCC LP:

Primary Outcome Measures:
  • length of gestation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gestational weight [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 452
Study Start Date: August 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 48 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344616

Locations
United States, Colorado
PHCC LP
Pueblo, Colorado, United States, 81003
Sponsors and Collaborators
PHCC LP
  More Information

No publications provided

Responsible Party: James G. Christian, President, PHCC LP
ClinicalTrials.gov Identifier: NCT01344616     History of Changes
Other Study ID Numbers: 2 R44 HD47031-02A2
Study First Received: July 27, 2010
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by PHCC LP:
computer-based behavioral support

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Body Weight
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014