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Premature BirthIPC-MNCT00852319

Interpregnancy Care Project-Mississippi (IPC-M)

A study testing Interpregnancy Care in people with Premature Birth, run by University of Mississippi Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 to 44 years, women only
Conditions the study is for
Premature Birth
What is being tested?
Interpregnancy Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
3 sitesUnited States
Study dates
Feb 2009to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 44 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Mississippi State Department of Health

    Jackson, Mississippi, 39215

  • Federally Qualified Community Health Centers

    Jackson, Mississippi, 39216

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

Other trials in United States

About this study

Official title: Interpregnancy Care Project-Mississippi

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.

Read the detailed 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.

Conditions
Premature Birth
Being tested
Interpregnancy Care
Keywords
Interpregnancy Care, Preconceptual Care, Premature Birth, Preterm Delivery
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interpregnancy CareBehavioural

    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 CareBehavioural

    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.

Study groups in NCT00852319
Study groupRoleWhat they receive
Central Mississippi groupExperimentalParticipants 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.
Receives: Behavioral: Interpregnancy Care
Mississippi Delta groupExperimentalParticipants 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.
Receives: Behavioral: Interpregnancy Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (3)
  1. 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.

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

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

    Measured: Health status is assessed throughout the study.

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00852319
Sponsor's protocol ID
2009-0017
Acronym
IPC-M
Status last verified
Jan 2016
First submitted
25 Feb 2009
Last updated
15 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17712612

Questions about this trial

What is this clinical trial studying?

A study testing Interpregnancy Care in people with Premature Birth, run by University of Mississippi Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The average number of pregnancies conceived within 18 months of the index delivery. (time frame: The first 18 months the participant is enrolled in the study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00852319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.

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