Reducing Disparities in Birth Outcomes: a Randomized Controlled Trial of CenteringPregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,350
- 试验地点
- 8
- 主要终点
- Preterm birth
研究概览
简要总结
The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral outcomes, and decrease the racial difference in selected birth outcomes among African American and White women, compared to individual prenatal care.
详细描述
This is a randomized controlled trial to compare biomedical, behavioral and psychosocial outcomes by race 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 trial 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
- •Pregnant women aged between 14-45 years
- •Entry prenatal care before 20 6/7 weeks gestational age (defined as attendance at the intake screening visit). Patients must be randomized by 23 6/7 weeks gestational age.
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
Preterm birth
时间窗: Measured at delivery
Delivery before 37 weeks gestation
次要结局
- Patient activation measure(Measured at <20 week and 32-36 week of gestational age)
- Gestational weight gain(Measured at delivery)
- Birth weight(Measured at delivery)
- APGAR score(Measured at delivery)
- Gestational hypertension(Measured during pregnancy)
- Gestational diabetes incidence(Measured during pregnancy)
研究者
Moonseong Heo
Contact Principal Investigator
Clemson University