Phase 2
N=482
Reducing Preterm Births in Underserved Pregnant Women
Preterm Birth · Low Birth Weight <2500 Grams · Verylow Birthweight <1500 Grams
Bottom Line
View on ClinicalTrials.gov: NCT01344616 ↗Enrolled (actual)
482
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Birthweight — 40; 26 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lifestyle support (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- PHCC LP
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Birthweight |
40; 26 | — |
| SECONDARY Gestational Weight |
— | — |
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.
Eligibility Criteria
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. -
Data sourced from ClinicalTrials.gov (NCT01344616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.