Reducing Preterm Births in Underserved Pregnant Women
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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 |
- length of gestation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- 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 |
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. -
Contacts and Locations 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 Signs and Symptoms |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on June 17, 2013