跳至主要内容
临床试验/NCT07488091
NCT07488091招募中不适用

Multi Disciplinary Sickle Cell Disease Obstetrics Care Program in Ghana: Non-academic vs Academic Hospital (Pilot Study)

University of Ghana Medical School1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2026年1月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
198
试验地点
1
主要终点
Maternal mortality

研究概览

简要总结

The goal of this observational study is to determine the feasibility and effectiveness of initiating a multidisciplinary sickle cell disease (SCD) obstetrics program for women with SCD in a non-academic hospital.

The main question it aims to answer is: In a before-and-after study design, we will test the hypothesis that multidisciplinary care for pregnant women with SCD in a non-academic hospital will result in a 50% relative risk reduction in mortality compared to the mortality rate in pregnant women with SCD in the same hospital before the multidisciplinary care.

Participants will be managed using the academic hospital's multidisciplinary sickle cell disease obstetrics protocol adapted for the non-academic hospital

详细描述

Sub-Saharan Africa has a high burden of sickle cell disease (SCD). Approximately 300,000 children are born with SCD in Sub-Saharan Africa yearly (Piel et al. 2013). Ghana is one of the most SCD-burdened countries, with 2% (approximately 18,000) newborns delivered with SCD each year (Ohene-Frempong et al. 2008). Compared with the United States of America and the United Kingdom, 2,400 and 300 newborns, respectively, are born with SCD each year.

Many children with SCD living in low-resource settings, particularly urban areas, are now surviving into childbearing years and adulthood due to general improvements in healthcare. With increasing life expectancy in Africa, pregnancy has become an emerging life-threatening complication in women with sickle cell disease (SCD). In low and middle-income countries (LMICs), the odds ratio of maternal death associated with SCD is 22.81 (95% CI 14.67-35.46) (Boafor et al. 2016). The nearly 23-fold increased odds of death are primarily due to SCD-related severe complications (Boafor et al. 2016). There were no evidence-based guidelines for managing pregnant women with SCD in low-resource settings. To address this, from 2012-2014, the Obstetrics Department at Korle-Bu Teaching Hospital (the flagship academic hospital) in Accra, Ghana, established a dedicated SCD Obstetrics clinic based on guidelines adapted from the American College of Obstetrics and Gynecology. The Institutional maternal mortality for women with SCD over these three years (2012-2014) was approximately 12%.

In January 2015, a multidisciplinary SCD obstetrics team, composed of local and international experts, was established at the flagship academic hospital to provide comprehensive care for this high-risk population. The local team included two obstetricians, three hematologists, two midwives, two laboratory scientists, a pediatrician, and a dual-certified anesthesiologist/ pulmonologist. The team conducted a combined retrospective/ prospective case series of all maternal deaths in women with SCD at Korle-Bu Teaching Hospital (the flagship academic hospital in Ghana) over seven years (2010-2016) (Asare et al. 2018). This retrospective data collection highlighted challenges to delivering improved care. Acute chest syndrome, preceded by acute pain episodes, was the leading cause of death in nearly 87% of women (Asare et al. 2018). In May 2015, the team established a joint obstetrics/hematology clinic, instituted close maternal and fetal monitoring, and implemented clinical guidelines/ protocols (including protocols for antenatal care, labor and delivery, postnatal care, and the management of SCD-related complications). In addition, the multidisciplinary SCD obstetrics team established a weekly communication system to adjudicate the management of challenging cases. These interventions resulted in an 89.1% relative risk reduction in maternal mortality (from 10,791 to 1,176 deaths per 100,000 live births; p=0.007) over 13 months (May 2015 - May 2016) (Asare et al. 2017). Since initiating the multidisciplinary SCD obstetrics program, the investigators have consistently decreased maternal mortality in this cohort by approximately 90% compared to before the team was established (Oppong et al. 2019; Swarray-Deen et al. 2022).

Despite overwhelming evidence of the positive impact of the multidisciplinary SCD obstetrics team, the team is restricted to the flagship academic hospital and faces numerous competing demands. Before the creation of the multidisciplinary SCD obstetrics team at Korle-Bu Teaching Hospital, the care of pregnant women with SCD in Ghana, including the investigators' study site, was obstetrician-led. After 7 years, the intervention has increased reach (the proportion of pregnant women with SCD who have received multidisciplinary SCD obstetric care divided by the total number of eligible pregnant women with SCD receiving care in facilities in the Greater Accra Region) from 0% to 20%. While there is a reduction in the maternal mortality ratio in women with SCD at Korle-Bu Teaching Hospital (the flagship academic hospital), the investigators' current reach of approximately 20% is too small to achieve the public health impact of decreased maternal mortality in this cohort in other parts of the Greater Accra Region, where more than 80% of pregnant women with SCD are seen. To reduce maternal mortality in women with SCD living in Ghana (with 16 regions) and elsewhere, the investigators must have a better implementation and scale-up strategy to increase the reach of multidisciplinary SCD obstetrics care in the Greater Accra Region.

There is an unequal distribution of human resources for health in Ghana (Asamani et al. 2021). Academic hospitals have a more significant proportion of highly trained medical personnel than non-academic hospitals. Conducting research and implementing findings into usual care is far more feasible in academic hospitals because of the availability of trained health personnel and other resources. For equitable translation of "research to practice" to be achieved, non-academic hospitals need to participate in conducting these research studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with a confirmed laboratory diagnosis of sickle cell disease
  • Pregnancy confirmed by a pelvic ultrasound scan
  • Pregnancy should be 34 weeks' gestation or less
  • Pregnant women should be aged 18 - 45 years
  • Pregnant women should be attendants at the non-academic hospital

排除标准

  • All pregnant women with sickle cell disease who do not provide informed consent
  • All pregnant women with sickle cell disease who are referred for management of acute complications and hospital admission
  • All pregnant women with sickle cell disease who are referred for labor and delivery
  • All pregnant women with SCD who plan on delivering outside the non-academic hospital and won't be able to adhere to the follow-up procedures during the puerperium (the first six weeks after childbirth)

结局指标

主要结局

Maternal mortality

时间窗: Up to 40 weeks for each participant

Maternal mortality in women with sickle cell disease

次要结局

未报告次要终点

研究者

发起方
University of Ghana Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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