Philadelphia Preterm Prevention Project

NCT01117922 | Completed

• 1 other identifier: IRB#09-007191
• Study Type: interventional
• Target: 1,136
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

preterm birth; interconceptional intervention; pregnancy outcomes

Outcome Measures

Primary Outcomes (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.

  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.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Psychological intervention

Usual Care Group

OTHER

This group will receive usual care.

Other: Usual Care Group

Interventions

Psychological intervention OTHER

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.

Intervention

Usual Care Group OTHER

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 25361563 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer Culhane, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 6, 2010
• Study Start: November 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 12, 2015

Record last verified: 2010-05

Locations

US (1)