NCT01117922

Philadelphia Preterm Prevention Project

Philadelphia Collaborative Preterm Prevention Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,136 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
OTHER	Psychological intervention	Subjects will be randomized into either usual care or interconceptional intervention groups. If the subject is randomized into the intervention group, she will receive targeted interventions to reduce one of several risk factors: smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate BMI. A woman who is randomized to the intervention group may receive interventions on one, two, three, four, or five of the targeted intervention methods, depending on her needs.
OTHER	Usual Care Group

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2010-05-06
• Last updated: 2015-03-12

Locations

1 site across 1 country: United States