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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interpregnancy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
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.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mississippi State Department of Health, Federally Qualified Community Health Centers
- Responsible party
- Principal investigator, Glen Graves, University of Mississippi Medical Center
- Investigators
- Glen Graves, MD, Principal investigator, University of Mississippi Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpregnancy Care Project-Mississippi
- ClinicalTrials.gov ID
- NCT00852319
- Acronym / sponsor ID
- IPC-M / 2009-0017
- Conditions
- Premature Birth
- Keywords
- Interpregnancy Care, Preconceptual Care, Premature Birth, Preterm Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Mississippi State Department of Health, Federally Qualified Community Health Centers
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central Mississippi group | Experimental | Behavioral: Interpregnancy CareParticipants 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. |
| Mississippi Delta group | Experimental | Behavioral: Interpregnancy CareParticipants 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. |
Who may qualify
- Ages
- 13 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpregnancy CareThe 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. | Behavioural | Central Mississippi group |
| Interpregnancy CareThe 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. | Behavioural | Mississippi Delta group |
Primary outcome
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.
3 secondary outcomes
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.
Time frame: 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.
Time frame: Health status is assessed throughout the study.
The financial costs and feasibility of providing interpregnancy care to this high-risk population.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Background: PubMed 17712612Dunlop 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Graves, MD principal investigator
University of Mississippi Medical Center
3 sites in 1 country: see every site and its status.
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.