Group Antenatal Care in Ghana: Protocol for a Cluster Randomized Controlled Trial.

Group Antenatal Care in Ghana: Protocol for a Cluster Randomized Controlled Trial.
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DOI:
10.2196/40828
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发表时间:
2022-09-09
影响因子:
1.7
通讯作者:
Moyer, Cheryl A.
Moyer, Cheryl A.
中科院分区:
其他
文献类型:
--
作者:
Lori, Jody R.;Williams, John E. O.;Kukula, Vida A.;Apetorgbor, Veronica E. A.;Awini, Elizabeth A.;Amankwah, Georgina;Zielinski, Ruth;Lockhart, Nancy;James, Katherine H.;Moyer, Cheryl A.

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虽然团体产前护理(ANC)在高收入国家已经提供和研究了十多年,但直到最近才被引入撒哈拉以南非洲作为个人护理的替代方案。虽然高资源国家的研究实验设计在科学上是严格的,但研究结果不能推广到识字率低、孕产妇和新生儿发病率和死亡率高的低资源国家。集体产前护理提供项目是美国密歇根大学和加纳多多瓦健康研究中心之间的合作项目。GRAND是一项为期5年的整群随机对照试验(RCT)。我们的干预组ANC包括在第一次ANC访视时将相似胎龄的妊娠妇女分组为小组。然后,他们在建议的时间间隔内与同一组和同一名助产士会面。本研究旨在提高健康素养,提高分娩准备和并发症准备,并优化加纳东部地区七个农村卫生设施参加ANC的妇女的孕产妇和新生儿结局。将使用安全的数据收集网络应用程序和数据库管理工具在四个时间点收集定量数据。数据将在意向治疗的基础上进行分析,以测试两组之间的差异:随机分配到基于组的ANC的女性和随机分配到常规个体ANC的女性。我们将同时进行过程评估,以识别和记录患者,提供者和系统障碍以及程序实施的促进者。该研究于2018年9月获得资助。参与者的招募和登记以及数据收集于2019年7月开始。2021年11月,我们完成了研究的受试者入组(n=1761),并于2022年5月完成了妊娠晚期的数据收集(n=1284)。另外三个时间点的数据收集正在进行中:产后6周、产后6个月和产后1年。这项研究是重要的和及时的,因为它是第一个随机对照试验,以检查组ANC的影响,低识字和文盲的参与者。我们的研究结果有可能影响临床护理如何提供给全球和国内的低识字率人群,以改善孕产妇和新生儿的结局。ClinicalTrials.gov NCT 04033003; https://clinicaltrials.gov/ct2/show/NCT04033003 DERR 1 -10.2196/40828
While group antenatal care (ANC) has been delivered and studied in high-income countries for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. Although the experimental design of the studies from high-resource countries have been scientifically rigorous, findings cannot be generalized to low-resource countries with low literacy rates and high rates of maternal and newborn morbidity and mortality. The Group Antenatal Care Delivery Project (GRAND) is a collaboration between the University of Michigan in the United States and the Dodowa Health Research Centre in Ghana. GRAND is a 5-year, cluster randomized controlled trial (RCT). Our intervention—group ANC—consists of grouping women by similar gestational ages of pregnancy into small groups at the first ANC visit. They then meet with the same group and the same midwife at the recommended intervals for care. This study aims to improve health literacy, increase birth preparedness and complication readiness, and optimize maternal and newborn outcomes among women attending ANC at seven rural health facilities in the Eastern Region of Ghana. Quantitative data will be collected at four time points using a secure web application for data collection and a database management tool. Data will be analyzed on an intention-to-treat basis to test the differences between the two arms: women randomized to group-based ANC and women randomized to routine individual ANC. We will conduct a process evaluation concurrently to identify and document patient, provider, and system barriers and facilitators to program implementation. The study was funded in September 2018. Recruitment and enrollment of participants and data collection started in July 2019. In November 2021, we completed participant enrollment in the study (n=1761), and we completed data collection at the third trimester in May 2022 (n=1284). Data collection at the additional three time points is ongoing: 6 weeks postpartum, 6 months postpartum, and 1 year postpartum. This study is significant and timely because it is among the first RCTs to be conducted to examine the effects of group ANC among low-literacy and nonliterate 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. ClinicalTrials.gov NCT04033003; https://clinicaltrials.gov/ct2/show/NCT04033003 DERR1-10.2196/40828
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发表时间: 2012-05
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