Preterm Birth Clinical Trial
Official title:
Philadelphia Collaborative Preterm Prevention Project
This is a randomized clinical trial in which all Philadelphia resident women experiencing a pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be approached at the time of the postpartum hospital stay. Consenting women will be randomized into a usual care group or an interconceptional intervention targeting five risk conditions, all of which increase systemic inflammation. Our primary objective in this study is to assess the efficacy of our interconceptional intervention on the rate of repeat PTB.
This is a randomized clinical trial in which all Philadelphia resident women experiencing a
pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be
approached at the time of the postpartum hospital stay. Consenting women will be randomized
into a usual care group or an interconceptional intervention targeting five risk conditions,
all of which increase systemic inflammation. Our primary objective in this study is to
assess the efficacy of our interconceptional intervention on the rate of repeat PTB.
Participants will be randomized into one of two groups: usual care of interconceptional
intervention. Those who are randomized into the interconceptional intervention group will be
targeted for five risk conditions, including smoking, depression, infectious disease burden
and maternal stress, and achieving an appropriate BMI. It is hoped that by reducing these
seemingly disparate yet well-known risk conditions, we can reduce PTB and the subsequent
race/ethnic disparities.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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