Philadelphia Preterm Prevention Project

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Other: Psychological intervention; Other: Usual Care Group

• Registration Number: NCT01117922
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Status Verified: 2010-05
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-06
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Psychological intervention	After consent, subjects will be assigned to either a usual care group (no intervention) or an intervention group (targeted interconceptional interventions).
Usual Care Group	Usual Care Group	This group will receive usual care.

Primary Outcome Measures

Name	Time	Method
Reduction in PTB rate among women with a prior PTB can be achieved through interconceptional interventions targeting multiple as opposed to single risk factors.	Women in the intervention group will be assessed every 6 months through 24 months, unless they become pregnant, in which case they will be seen at 20 weeks EGA with their subsequent pregnancy.	If women do not become pregnant during the evaluation period of 24 months, they will be seen for study visits every 6 months, and will be seen more often for intervention measures to take place, as needed. For those who become pregnant in the evaluation period, they will be assessed at 20 weeks EGA with their subsequent pregnancy, and asked to sign a release for their subsequent pregnancy records.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States