Interpregnancy Care Project-Mississippi (IPC-M)

Premature Birth Clinical Trial

— IPC-M  

Official title:

Interpregnancy Care Project-Mississippi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852319
• Other study ID #: 2009-0017
• Status: Completed
• Phase: N/A
• First received: February 25, 2009
• Last updated: January 13, 2016
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 44 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

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

Intervention

Behavioral:
• Interpregnancy Care
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.
• Interpregnancy Care
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.

Locations

Country	Name	City	State
United States	Federally Qualified Community Health Centers	Jackson	Mississippi
United States	Mississippi State Department of Health	Jackson	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Federally Qualified Community Health Centers, Mississippi State Department of Health

Country where clinical trial is conducted

United States, 

References & 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. Epub 2007 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average number of pregnancies conceived within 18 months of the index delivery.		The first 18 months the participant is enrolled in the study.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No