Philadelphia Preterm Prevention Project (PPP)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Preterm Birth

Treatments: Other: Psychological intervention; Other: Usual Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01117922

IRB#09-007191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,136 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• delivery of live born infant at <34 weeks of gestation in one of 18 Philadelphia area hospitals
• English or Spanish speaking
• Philadelphia residency
• not receiving operative sterilization before discharge from the hospital

Exclusion criteria

• N/A

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,136 participants in 2 patient groups

Intervention

Experimental group

Description:

After consent, subjects will be assigned to either a usual care group (no intervention) or an intervention group (targeted interconceptional interventions).

Treatment:

Other: Psychological intervention

Usual Care Group

Other group

Description:

This group will receive usual care.

Treatment:

Other: Usual Care Group