Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,133
- 试验地点
- 2
- 主要终点
- Prevalence of placental chronic inflammatory lesions, characterized histologically
研究概览
简要总结
The purpose of the PIINC study is to identify differences in placental inflammatory lesions between women participating in group prenatal care versus standard prenatal care, and additionally, examine whether the frequency of placental inflammatory lesions differ by race and income. The investigators hypothesize that women participating in group prenatal care will have lower pro-inflammatory profiles compared to women in routine prenatal care.
详细描述
This is a supplementary investigation of placental inflammatory lesions among participants enrolled in a randomized controlled trial comparing biomedical, behavioral and psychosocial outcomes among pregnant women who participate in CenteringPregnancy group prenatal care, to women in the traditional individual prenatal care and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of CenteringPregnancy on outcomes and health disparities. The study will be conducted in a large prenatal care center in South Carolina. Eligible White and Black women will be recruited before 20 weeks of gestational age with low risk pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
- •Pregnant women aged between 14-45 years
- •Enrolled in prenatal care by 20 6/7 weeks' gestation
排除标准
- •Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care
- •Pregestational diabetes,
- •Severe chronic hypertension requiring medication,
- •Morbid Obesity with BMI >49.99
- •Renal disease with baseline proteinuria >1g/24 hours
- •Any disease requiring chronic immunosuppression (SLE, solid organ transplant)
- •Active pulmonary tuberculosis
- •Sickle cell anemia
- •Human Immunodeficiency Virus Infection
- •Other medical conditions that would exclude women from group care at the discretion of the PI
- •Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care
- •Multiple gestation
- •Lethal fetal anomalies
- •Other pregnancy complications that would exclude women from group care at the discretion of the PI
- •Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care
- •Current incarceration
- •Severe psychiatric illness
结局指标
主要结局
Prevalence of placental chronic inflammatory lesions, characterized histologically
时间窗: Measured at delivery
Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
时间窗: Measured at delivery
次要结局
- Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays(Up to 43 weeks gestation)
- Differential expression of mRNA gene transcripts for 34,000 human genes(Measured at delivery)
研究者
Ann Borders
Principal Investigator
NorthShore University HealthSystem