跳至主要内容
临床试验/NCT04100577
NCT04100577已完成不适用

Addressing Black Infant Mortality in Wisconsin Through a Collaborative Health Equity Approach Through Community Based Group Prenatal Care and Infant Support

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Participant recruitment as assessed by percentage of participants enrolled in Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)

研究概览

简要总结

This pilot project aims to implement and investigate the feasibility and acceptability of a unique community based prenatal care and support model for African American women and infants in Dane County. The model, the "Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)" builds on emerging evidence about how to effectively implement and sustain prenatal care in black communities. It combines three approaches-community-based doula programs; group-based models of prenatal care, such as Centering Pregnancy; and community-based pregnancy support groups-into once monthly group sessions held during the prenatal and immediate postpartum period. The project is based at the Today Not Tomorrow Family Resource Center in Madison's East Side Community Center, and carried out in close collaboration with Project Babies, Harambee Village Doulas, and the African American Breastfeeding Alliance of Dane County, Inc.

详细描述

Wisconsin leads the nation in the number of African American babies dying before their 1st birthday. These deaths are primarily due to complications of prematurity - babies being born too early and too soon. Additionally, Wisconsin's black infant mortality rate is significantly higher than that of whites and represents a serious health inequity that is critical for local research and advocacy efforts to address. The factors leading to inequities in preterm birth and infant mortality are complex and multifactorial; therefore, multidisciplinary and innovative approaches to prenatal and inter conception care are critical to improve these outcomes.

Previous research and feedback from black women living in Dane County has shown that lack of social support and culturally relevant models of preconception, prenatal, and inter-conception care has been a barrier to optimal quality of care and maternal child health outcomes. Further research has demonstrated that evidence based intervention approaches used nationally such as a) community-based doula programs, b) group-based models of prenatal care such as Centering Pregnancy, and c) community-based pregnancy and inter conception support groups hold promise as relevant prevention strategies, yet there are many barriers to their effective adoption in communities of color.

In response to the current birth outcome inequities that exist in Wisconsin, the objective of the current proposal is to implement and investigate a novel approach that combines aspects of all three of the above-mentioned evidence-based models and builds upon emerging evidence about how to effectively implement and sustain prenatal care interventions in Black communities: the TNT-PISP. The TNT-PISP approach is based on increasing evidence that models of prenatal care that are community driven, group based, culturally relevant, family centered, and include enhanced social support have the potential to significantly decrease African American prematurity rates and improve other maternal and infant health measures.

TNT-PISP is a collaborative community-based support group uniquely designed to serve black women and infants through once monthly group sessions delivered prenatally and in the immediate postpartum period. Each 2 hour TNT-PISP session will be held at the Today Not Tomorrow Family Resource Center located on Madison's Eastside and will be led by local African American community-based doulas supported by and in collaboration with a host of other community partners and healthcare professionals from diverse backgrounds. Each session will consist of food, hands on learning activities, peer to peer socio-emotional support, guest speakers, relationship building activities, and dynamic discussions on a host of pregnancy and newborn care related topics. In addition to group sessions, participants will be additionally have the option to be enrolled in a community based doula program to receive support outside the group sessions, and culturally sensitive mental health and case management support services on an as-needed basis. Via partnerships with various healthcare providers and systems, there are also tentative plans for future expansion so that select participants will additionally be able to receive their prenatal care exams on site.

Assessments with individual participants in each study arm will occur at three contact points: At start of pregnancy, around time of birth/early postpartum and ~ 6 months postpartum. At each time of contact, they will be asked to complete a series of questionnaires and participate in a semi-structured interview with PI. If additionally consented, medical records of all study participants will be analyzed to assess secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant self- identified black women
  • Living in Dane County Wisconsin

排除标准

  • Not pregnant or did not deliver within the last year
  • Do not self- identify as a black woman

结局指标

主要结局

Participant recruitment as assessed by percentage of participants enrolled in Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)

时间窗: 2 years

TNT-PISP is aiming to recruit 20 self-identified African American women into the TNT-PISP Pilot. The actual recruitment will be measured as percentage of participants recruited, assuming recruitment of 20 participants per arm as 100%

Retention rate of participants as assessed by percentage of participants adhered to study for 2 years

时间窗: 2 years

Retention rate of participants as assessed by percentage of participants adhered to study for 2 years

次要结局

  • Preliminary Maternal Child Health Outcomes: Birth weight(At child birth or at 38 week average gestation time whichever will come first)
  • Preliminary Maternal Child Health Outcomes: Birth gestational age(At child birth or at 38 week average gestation time whichever will come first)
  • Percentage of participants breastfed babies at time of birth(up to 2 years)
  • Percentage of participants opted for inter-conception care plans(2 years)
  • Rate of attendance to 6- week postpartum visit(6 week postpartam)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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