Interpregnancy Care Project-Mississippi (IPC-M)

NCT00852319 | Completed

• 1 other identifier: 2009-0017
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 3

Brief Summary

The IPC program will enroll women who deliver Very Low Birth Weight babies (stillborn or liveborn) at University of Mississippi Medical Center and women who have Very Low Birth Weight babies that receive treatment in the Neonatal Intensive Care Unit at University of Mississippi Medical Center and provide each woman with 24 months of funded comprehensive, integrated, primary health care services (including family planning, social services, general medical services,and basic dental care), and enhanced case management. The services will be community-based (via UMC Clinics, community health centers, and outreach programs) and will be provided by a multidisciplinary team of physicians, nurses, social workers, case managers, and Resource Mothers/Resource Workers. At the end of project follow-up, we will evaluate the success of the program in terms of improvement of general health status of enrolled women, and subsequent reproductive health outcomes (i.e., achieving reproductive intentions, intendedness and spacing of subsequent pregnancies, birth weight distribution of subsequent pregnancies) and cost of delivery services compared to reproductive health outcomes in the project's control population.

Conditions

Premature Birth

Keywords

Interpregnancy Care; Preconceptual Care; Premature Birth; Preterm Delivery

Outcome Measures

Primary Outcomes (1)

• The average number of pregnancies conceived within 18 months of the index delivery.

  The first 18 months the participant is enrolled in the study.

Secondary Outcomes (3)

• The average number of adverse outcomes for pregnancies conceived within 18 months of the index delivery. Adverse outcomes include such events as preterm birth, miscarriage, stillbirth, low birth weight, and small size based upon gestational age.

  The first 18 months the participants are enrolled in the program.

• The health status of participants after participating in the study, highlighting the issues strongly associated with VLBW infants, such as diabetes, hypertension, and obesity.

  Health status is assessed throughout the study.

• The financial costs and feasibility of providing interpregnancy care to this high-risk population.

  Over the course of this five-year study, the cost of providing interpregnancy care to this population will be compared to the general costs incurred by the control group that did not receive interpregnancy care.

Study Arms (2)

Central Mississippi group

EXPERIMENTAL

Participants from central Mississippi are provided with 24 months of interpregnancy care. The results from this arm are compared to a historical control group (who were not given interpregnancy care) from the same geographical area in Mississippi.

Behavioral: Interpregnancy Care

Mississippi Delta group

EXPERIMENTAL

Participants from 18 counties of the Mississippi delta are provided with 24 months of interpregnancy care. The results from this arm are compared to a historical control group (who were not given interpregnancy care) from the same geographical area in Mississippi.

Behavioral: Interpregnancy Care

Interventions

Interpregnancy Care BEHAVIORAL

The intervention package includes: 1) Creation of an individualized interpregnancy care plan based on assessments of risks for subsequent poor pregnancy outcomes; 2) Basic dental care and provision of primary health care services for 24 months; 3) Assistance in achieving a woman's desire for subsequent pregnancies and her need for optimum child spacing (ideally at least 18 months); 4) Provision of appropriate social services and community outreach in each woman's community.

Central Mississippi group

Eligibility Criteria

• Age: 13 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• African American female
• Delivery of a VLBW (below 1500 grams) infant at University of Mississippi Medical Center; can be liveborn or stillborn
• Transfer of an otherwise-qualifying VLBW infant to University of Mississippi Medical Center within two months of birth
• Indigent or Medicaid-eligible during pregnancy
• Maternal residence in Hinds county or in one of the 18 delta counties in Mississippi's Federal Health Districts I, III, or V

You may not qualify if:

• Non-English speaking women
• Pregnant women are excluded because the program is designed to study the benefits of providing primary health care services during the interpregnancy period
• Women who are incarcerated or who are institutionally committed will be excluded because they will not be available to participate in the intervention package.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Mississippi State Department of Health: collaborator
• Federally Qualified Community Health Centers: collaborator

Study Sites (3)

Mississippi State Department of Health

Jackson, Mississippi, 39215, United States

Location

Federally Qualified Community Health Centers

Jackson, Mississippi, 39216, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• Dunlop AL, Dubin C, Raynor BD, Bugg GW Jr, Schmotzer B, Brann AW Jr. Interpregnancy primary care and social support for African-American women at risk for recurrent very-low-birthweight delivery: a pilot evaluation. Matern Child Health J. 2008 Jul;12(4):461-8. doi: 10.1007/s10995-007-0279-z. Epub 2007 Aug 22.

  PMID: 17712612 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Glen Graves, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 27, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (3)