Overview

This trial is active, not recruiting.

Conditions preterm birth, low birth weight <2500 grams, verylow birthweight <1500 grams
Treatment lifestyle support
Phase phase 2
Sponsor PHCC LP
Start date August 2010
End date July 2013
Trial size 452 participants
Trial identifier NCT01344616, 2 R44 HD47031-02A2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
usual clinical care with no intervention
(Experimental)
computer-based clinical support to patient
lifestyle support
computer-based lifestyle improvement support and clinician support

Primary Outcomes

Measure
length of gestation
time frame: 9 months

Secondary Outcomes

Measure
gestational weight
time frame: 9 months

Eligibility Criteria

Female participants from 16 years up to 48 years old.

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. -

Additional Information

Official title Reducing Preterm Births in Underserved Pregnant Women
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by PHCC LP.