Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial

项目摘要/摘要 这项建议，团体产前护理，促进健康孕期，优化母婴 结果：一项整群随机对照试验，对PAR-16-160有反应，并建立在我们最近的Fogarty基础上 国际/美国国立卫生研究院资助的加纳研究(1 K01 TW008763-01A1，Lori Pi)。我们的研究是由一个 理论模型最初是由Squiers等人开发的。并在我们的初步研究中进行了修改以评估 孕产妇健康素养。修改后的母亲健康素养技能框架使用了一种生态 帮助开发和测试影响卫生知识普及的潜在干预措施。 我们的干预措施，团体产前护理(ANC)，包括将相似胎龄的妇女分组为 非国大第一次访问时的小团体。然后，他们在课程中与相同的小组和相同的提供商会面 关于她们怀孕的事。用于进行小组访问的模型是在低收入和低收入人群中开发和测试的 在Fogarty的资助下，由PI在加纳的非识字孕妇，在准实验中，两组 产生良好行为结果的比较研究。在本研究中，我们提出了三个目标：目标1： 量化分娩准备和并发症准备(BPCR)的差异，包括以下知识 危险征兆和建议的行动步骤之间的妇女随机参加基于组的ANC和常规， 个人非国大。目标2：评估求医模式中的行为差异(例如，设施出生率， 产后和产后护理)在随机分为基于群体的ANC和常规的个体ANC的妇女之间。 目标3：评估母亲及其新生儿的临床结果(例如，母亲发病率的降低 和围产儿和新生儿死亡率)之间的妇女随机分组的ANC和常规，个人 ANC产后即刻和出生后最多一年。我们假设怀孕的女性 被随机分为ANC组的ANC将通过以下方式表现出更高的健康素养：1)增加BPCR值，包括 对危险征兆的认识和如何应对这些征兆的知识；2)更高的求诊率 行为，包括为怀孕期间发现的问题寻求护理，较高的机构接生率，以及 增加产后护理；以及3)改善自己和新生儿的临床结局 比接受标准的、个人的ANC的女性更多。为了检验我们的假设，我们建议进行一项 东曼普鲁西地区按地点和胎龄分层的整群随机对照试验 加纳北部地区，一个以农村为主的地区。我们将对妇女及其新生儿进行为期一年的跟踪调查 邮寄。为了检查临床和行为结果，数据收集将通过手机进行， 面对面的面谈和病历的复查。这项研究是有意义的和及时的，因为它是 首次进行随机对照试验，以检验低识字率和非识字率的ANC组的效果 参与者。我们的发现有可能影响低识字率人群的临床护理 全球和国内的人口，以改善孕产妇和新生儿的结局。

Project Summary/Abstract This proposal, Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial, responds to PAR-16-160, and builds on our recent Fogarty International/NIH funded study (1 K01 TW008763-01A1, Lori PI) in Ghana. Our study is guided by a theoretical model originally developed by Squiers et al. and modified in our preliminary research to assess maternal health literacy. The Modified Maternal Health Literacy Skills Framework uses an ecological perspective to help assist in the development and testing of potential interventions to impact health literacy. Our intervention, group antenatal care (ANC), consists of grouping women by similar gestational ages into small groups at the first ANC visit. They then meet with the same group and the same provider over the course of their pregnancy. The model used to conduct the group visits was developed and tested among low- and non-literate pregnant women in Ghana by the PI with funding from Fogarty, in a quasi-experimental, two-group comparison study that yielded favorable behavioral outcomes. In this study, we propose three aims: Aim 1: To quantify differences in Birth Preparedness and Complication Readiness (BPCR), including knowledge of danger signs and recommended action steps between women randomized to group-based ANC and routine, individual ANC. Aim 2: To assess behavioral differences in care-seeking patterns (e.g. facility birth rates, postnatal and postpartum care) between women randomized to group-based ANC and routine, individual ANC. Aim 3: To evaluate the clinical outcomes of mothers and their newborns (e.g. decrease in maternal morbidities and perinatal and neonatal mortality) between women randomized to group-based ANC and routine, individual ANC immediately postpartum and up to one year following birth. We hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1) increased BPCR including recognition of danger signs and knowledge of how to respond to such signs; 2) higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal care; and 3) better clinical outcomes for themselves and their newborns than women who received the standard, individual ANC. To test our hypotheses, we propose to conduct a cluster randomized control trial stratified by site and gestational age in the East Mamprusi District of the Northern Region of Ghana, a predominantly rural area. We will follow women and their newborns for one-year post delivery. To examine clinical and behavioral outcomes, data collection will be conducted via cellphones, face-to-face interviews, and medical record review. This study is significant and timely because it is one of the first randomized control trials to be conducted to examine the effects of group ANC with low and non-literate participants. Our findings have the potential to impact how clinical care is delivered to low literacy populations both globally and domestically to improve maternal and newborn outcomes.