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Phase 2 Completed N=482 Randomized Prevention

Reducing Preterm Births in Underserved Pregnant Women

Preterm Birth · Low Birth Weight <2500 Grams · Verylow Birthweight <1500 Grams
Source: ClinicalTrials.gov NCT01344616 ↗
Enrolled (actual)
482
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Birthweight — 40; 26 participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Birthweight
40; 26
SECONDARY
Gestational Weight

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. -
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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