Reducing disparities in birth outcomes: a randomized controlled trial on CenteringPregnancy

 描述（由申请人提供）：早产（PTB）在美国（U.S.）发生率高得令人无法接受，黑人女性受到精神影响。迄今为止，医疗和公共卫生干预措施在改善生育结果方面取得的成功有限。问题的部分原因可能是过去几十年的努力主要集中在增加产前护理的机会。出生结果的病因是复杂的，涉及行为，心理，社会人口，社区，环境和医学因素。怀孕期间的心理社会因素（如压力，焦虑，抑郁和应对反应）越来越受到关注，成为不良出生结果的关键因素。不全面处理这些更广泛因素的干预措施可能不太能够取得成功。CenteringPregnancy小组产前护理（GPNC）的研究，其中个人的身体评估与便利的小组教育和同伴支持相结合，已经证明了有希望的结果，包括产前护理使用率和护理满意度高，PTB率提高。由于GPNC提供了社会支持和更多的访问时间，增加了患者教育，自我护理技能和授权，因此它具有 改善出生结果和减少出生结果种族差异的巨大潜力。然而，还没有研究最终确定GPNC对PTB的影响，或者这种护理模式对PTB种族差异的影响。先前的研究也没有建立 GPNC对患者的教育，激活和压力的影响，这可能会影响分娩结局以及产后期后的健康行为和结局。为了填补这一研究空白，我们建议进行一项随机对照试验（RCT），比较参加GPNC的孕妇与传统个体产前护理（IPNC）的妇女之间的生物医学，行为和心理社会结果，并调查改善妇女的压力，激活和参与是否会解释GPNC对结果和健康差异的潜在益处。该试验将在南卡罗来纳州的一个大型产前护理中心进行，该中心的历史PTB率高达16.4%。合格的白色和黑人女性将在胎龄20周前招募，并将随访至分娩和产后6周。

 DESCRIPTION (provided by applicant): Preterm birth (PTB) occurs at unacceptably high rates within the United States (U.S.), with Black women disproportionally affected. To date, medical and public health interventions have achieved limited success in improving birth outcomes. Part of the problem could be that the efforts in the last several decades focused mainly on increasing access to prenatal care. The etiology of birth outcomes is complex, involving behavioral, psychosocial, socio-demographic, community, environmental, and medical factors. Psychosocial factors during pregnancy (e.g. stress, anxiety, depression, and coping responses) are gaining increased attention as critical contributing factors to poor birth outcomes. Interventions that do not address these broader factors in a comprehensive way may be less able to achieve success. Studies of CenteringPregnancy group prenatal care (GPNC), where individual physical assessments are combined with facilitated group education and peer support, have demonstrated promising results, including high rates of prenatal care use and care satisfaction, and improvements in PTB rates. Because GPNC provides social support and more time for visits, increasing patient education, skills for self-care, and empowerment, it holds great potential for improving birth outcomes and reducing racial disparities in birth outcomes. However, no study has yet conclusively determined the effects of GPNC on PTB in general, or the effect of this care model on racial disparities in PTB. Prior research has also not established GPNC effects on patient education, activation, and stress, which may influence birth outcomes as well as health behaviors and outcomes beyond the postpartum period. To fill this research gap, we propose to conduct a randomized controlled trial (RCT) to compare biomedical, behavioral and psychosocial outcomes by race among pregnant women who participate in GPNC, to women in the traditional individual prenatal care (IPNC) and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of GPNC on outcomes and health disparities. The trial will be conducted in a large prenatal care center in South Carolina where the historical PTB rate has been as high as 16.4%. Eligible White and Black women will be recruited before 20 weeks of gestational age and will be followed to delivery and 6 weeks postpartum.