Reducing Preterm Births in Underserved Pregnant Women

Preterm Birth Clinical Trial

Official title:

Reducing Preterm Births in Underserved Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344616
• Other study ID #: 2R44HD047031-02A2
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2010
• Last updated: November 19, 2014
• Start date: August 2010
• Est. completion date: October 2013

Study information

• Verified date: November 2014
• Source: PHCC LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 48 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Low Birth Weight <2500 Grams
• Premature Birth
• Preterm Birth
• Verylow Birthweight <1500 Grams

Intervention

Behavioral:
• lifestyle support
computer-based lifestyle improvement support and clinician support

Locations

Country	Name	City	State
United States	PHCC LP	Pueblo	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
PHCC LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birthweight	Birth weight < 2500 grams	9 months	No
Secondary	Gestational Weight		9 months	No