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Philadelphia Preterm Prevention Project (PPP)

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ClinicalTrials.gov Identifier: NCT01117922
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Preterm Birth Other: Psychological intervention Other: Usual Care Group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Philadelphia Collaborative Preterm Prevention Project
Study Start Date : November 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

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.
Usual Care Group
This group will receive usual care.
Other: Usual Care Group



Primary Outcome Measures :
  1. Reduction in PTB rate among women with a prior PTB can be achieved through interconceptional interventions targeting multiple as opposed to single risk factors. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117922


Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Jennifer Culhane, MD Children's Hospital of Philadelphia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01117922     History of Changes
Other Study ID Numbers: IRB#09-007191
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: May 2010

Keywords provided by Children's Hospital of Philadelphia:
preterm birth
interconceptional intervention
pregnancy outcomes

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications