Philadelphia Preterm Prevention Project (PPP)

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Psychological intervention; Other: Usual Care Group

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 Type: Interventional
• Enrollment (Actual): 1136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; After consent, subjects will be assigned to either a usual care group (no intervention) or an intervention group (targeted interconceptional interventions).	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; This group will receive usual care.	Other: Usual Care Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in PTB rate among women with a prior PTB can be achieved through interconceptional interventions targeting multiple as opposed to single risk factors.	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.	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.

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jennifer Culhane, MD, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Webb DA, Mathew L, Culhane JF. Lessons learned from the Philadelphia Collaborative Preterm Prevention Project: the prevalence of risk factors and program participation rates among women in the intervention group. BMC Pregnancy Childbirth. 2014 Nov 1;14:368. doi: 10.1186/s12884-014-0368-0.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 6, 2010

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: preterm birth; pregnancy outcomes; interconceptional intervention
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: IRB#09-007191