Effectiveness and Acceptability of Availing Skilled Birth Attendance (SBA) Services Through Community Reproductive Health Nurses (CORN) to a Household Level at Rural Communities of Ethiopia A Cluster Randomized Controlled Community Trial in Gedeo Zone, SNNPR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,670
- 试验地点
- 2
- 主要终点
- Percentage increase in skilled Delivery
研究概览
简要总结
Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and the majority of these deaths have been identified as being avoidable. A proxy indicator of Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal deaths. The Ethiopia health system has established a vast network of health infrastructure that extends to rural areas with the establishment of over 15,000 health posts and deployment of over 30,000 health extension workers throughout the country. Although these unprecedented situations made health services more accessible than ever, it is yet to be exploited for improving rural women's access to clean and safe delivery and postpartum care. Lack of usage of delivery care in the country is related not only to accessibility but also acceptability of the services. In fact, the vast majority of women with home deliveries saw institutional delivery as "unnecessary" and a "non-customary practice". Therefore, instituting an innovative, culturally sensitive, and practically amenable strategy, deployment of CORNs for example might be the best remedy, in this case.
Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural communities of Ethiopia.
Study design: Cluster Randomized Controlled Community Trial that will be conducted in four phases.
Study population: Study participants will be all pregnant women who will give birth at home and health facility (including health post) during the study period.
Intervention: The study will be conducted in four phases as discussed below. During the first (preparatory) phase, sensitization of relevant stakeholders and recruitment of trainees will be conducted. In the second phase, formative and baseline assessment as well as training of CORNs will take place. In the third phase, which will be actual intervention phase, deployment of CORNs in their respective study site will be done and in the final phase, final evaluation and dissemination of study findings will be done. The intension behind deploying CORNs to the grassroots level is just to give a backup skilled delivery and other MNH services to poor rural mothers who have difficult of accessing modern health facilities for various reasons; it has no any intention to promote or encourage home deliveries or replace institutional deliveries. Perhaps it will help to assimilate rural mothers to modern health facilities Main study parameters/endpoints: The main study end point is percentage of skilled birth attendance which is very low in local and national level. In addition secondary study parameters are percentage changes of maternal & related services uptakes. These include focused Antenatal; care (ANC), long term family planning, Prevention of Mother to Child Transmission of HIV (PMTCT) and postnatal care.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden and risks associated with participation to the study is very minimal. To mention few; physical examinations (Leopold manoeuvre) or the routine investigations of pregnancy this will be anonymous except for the CORNs keeping the principles of shared confidentiality in mind. Similarly all questionnaires or medical charts will be kept confidential. All CORNs will obtain intensive training on ethical principles that will help to minimize any physical and physiological discomfort associated with participation, the risks associated with the investigation treatment.
The study period and Budget: the study will be carried out in a total of 18 months which holds a period from the development of protocol to the terminal evaluation and submission of reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine hundred eighty seven dollars and ninety five cents
详细描述
Introduction Every year, 287,000 women die during pregnancy or childbirth, and 6.9 million children die before reaching their fifth birthday. Almost all these deaths occur in developing countries where mothers, children and newborns lack access to basic health care. While child mortality rates have declined in recent decades, 19,000 mothers still mourn the loss of a child each and every day - an unthinkable number of heartbreaks. This is especially tragic since most of these deaths could be prevented at a modest cost.
On the other hand, majority of maternal and newborn deaths are caused by complications or conditions that could be prevented or more effectively managed through inexpensive, low-technology measures. Majority of maternal and new born care deaths were followed by unskilled delivery attended at home. A study conducted in Basra about reasons reported by women who delivered at home for preferring home delivery have shown that social support and privacy was the predominant reason given by 98.2% of the women who had home delivery of their present child. Fear of interventions and repeated examinations at hospitals was the concern of 71.9% of the women who preferred home delivery. About 17.5% had an unplanned home delivery as a result of quick labor or the security situation did not allow transfer to hospital.
On the other hand, recent evidences illustrated that maternal deaths can be reduced with the posting of midwives (skilled attendant) if they have needed skills, supervision, and back-up . Evidences obtained from Bangladesh in 2004 suggested that, programme to create a cadre of skilled birth attendants for home births was launched by the Government . Accordingly, task-shifting seems to have yielded beneficial results and important insights into human resources planning for safe motherhood in the country. Another similar study by Ray AM on the impact of maternal mortality interventions using traditional birth attendants and village midwives showed that village midwives contribute to positive programme outcomes.
The presence of a skilled provider during childbirth and the immediate postpartum/newborn period is the single most critical intervention in saving the lives of women and newborns . The skilled provider can assist in normal deliveries and also manage or stabilize and refer for complications; all of which are critical interventions in reducing maternal and newborn mortality. The proportion of women who delivered with the assistance of a skilled birth attendant is one of the proxy indicators in meeting the fifth MDG. In almost all countries where health professionals attend more than 80% of deliveries, Maternal Mortality Rate (MMR)is below 200 per 100,000 live births [11]. However, birth with skilled attendance was low in Southern Asia (40%) and SSA (47%), the two regions with the greatest number of maternal deaths.
Though the program has addressed majority of the health problems at grass root level, maternal and child morbidity/ mortality rates of the nation is still one of the highest in the world. This is mainly attributable to the competency level of the rural health extension workers to provide cross-cutting maternity services on top of the deep rooted cultural, social and economic problems of the rural community. For example, a recent study in Tigray Region of Ethiopia showed that even if the HEWs have contributed substantially to the improvement in women's utilization of family Planning (FP), ANC and HIV testing, their contribution to the improvement in health facility delivery, postnatal check up and use of iodized salt seems insignificant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who are willing
- •Permanent residents
排除标准
- •Pregnant mother not from the selected Kebeles.
研究组 & 干预措施
CORN Based at health post
Trained CORN based at health post will provide SBA and other RH services on demand at health post or household levels on an outreach bases.
干预措施: trained midwives and nurses working in the community to provide skilled SBA services (Procedure)
CORN Based at health center
Trained CORN based at health center, but working in the community in an outreach basis will provide SBA and other RH services
干预措施: trained midwives and nurses working in the community to provide skilled SBA services (Procedure)
Control
will be composed of a randomly selected comparable controls clusters. Control clusters (arm) will be similar with the other two arms (groups) except for the intervention.
结局指标
主要结局
Percentage increase in skilled Delivery
时间窗: 9 month
This will be measured twice (baseline and end line survey using interviewer administered questionnaire).
Percent of stakeholders accepting CORN intervention
时间窗: 9 month
This will be measured twice (baseline and end line qualitative survey).
次要结局
- Percent of PMTCT uptake(9 month)
- Percent of FANC services uptake(9 month)
- Neonatal morbidity(9 month)
- Percent of FP (long term)services uptake(9 month)
- Percent of PNC services uptake(9 month)