Philadelphia Preterm Prevention Project (PPP)

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01117922
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention
Preterm Birth
Other: Psychological intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Philadelphia Collaborative Preterm Prevention Project

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 1136
Study Start Date: November 2004
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention vs. Usual care
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jennifer Culhane, MD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01117922     History of Changes
Other Study ID Numbers: IRB#09-007191
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014