Interpregnancy Care Project-Mississippi (IPC-M) — IPC-M  

Premature Birth Clinical Trial

Official title: Interpregnancy Care Project-Mississippi

Status Completed

Clinical Trial 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.

Clinical Trial Description

In the United States, Low Birth Weight (LBW; less than 2500 grams) delivery is the leading cause of infant mortality for African Americans. In addition, Very Low Birth Weight (VLBW; less than 1500 grams) deliveries frequently result in severe chronic health problems and lifelong disability in the surviving children. The racial disparity in infant mortality between African Americans and Caucasians is widening throughout the United States. Since Mississippi is the only state in the country with almost 50 percent of births to African Americans, the impact on Mississippi is dramatic. Recent research has focused on fetal origins of adult chronic diseases such as diabetes and hypertension. These findings confirm that poor pregnancy outcomes such as VLBW infants are often trans-generational problems. They are more common among women in poor health who lack continuous access to primary health care.

The best clinical predictor of a woman's delivery of a VLBW infant is her history of a previous VLBW delivery. The base line rate of very low birth weight for the general population is 1.5 percent of live births. After the first VLBW delivery, African American women have a 13.4 percent chance of another VLBW delivery. These figures are doubled in the case of teen pregnancies and progressively rise with each additional VLBW delivery. Mississippi has approximately 40,000 births per year; less than 2.5 percent (800) of these pregnancies result in 50 percent of infant deaths.

In Mississippi, Medicaid coverage is available to many women during their pregnancies, including a subset of women who do not financially qualify for Medicaid outside of pregnancy. The majority of these women lose Medicaid eligibility approximately 60 days after delivery; therefore, they do not have access to primary care resources. It appears that the strategy that offers the greatest potential for increasing a high risk woman's chance of having a full term healthy baby is preconceptual and inter-conceptual care.

The proposed project identifies and enrolls women in the Interpregnancy Care Project (IPC) of Mississippi at discharge from the hospital following the delivery of a VLBW infant. The IPC program provides 24 months of primary, continuous health care, basic dental care, enhanced nurse case management, and community outreach via a resource mother or resource worker. Primary health care addresses key areas epidemiologically linked to a VLBW delivery including the following: 1) reproductive planning and short interpregnancy intervals; 2) poorly-controlled chronic diseases; 3) reproductive tract infections; 4) nutritional disorders and obesity; 5) depression and domestic violence; 6) substance abuse; and 7) periodontal disease and cavities. Peer group meetings are integrated with IPC health care visits. Resource mothers and resource workers focus on parenthood preparedness, safe housing, job skills training, and education in the form of home visits and telephone contact. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Premature Birth

• NCT number: NCT00852319
• Study type: Interventional
• Source: University of Mississippi Medical Center
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Completion date: December 2013