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临床试验/NCT05385380
NCT05385380已完成不适用

Promoting Safe Motherhood in Ethiopia: A Cluster Randomized Controlled Trial

Prof Yves Jacquemyn1 个研究点 分布在 1 个国家目标入组 727 人开始时间: 2019年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
727
试验地点
1
主要终点
health facility visits after childbirth (postnatal care use)

研究概览

简要总结

Despite the efforts from the government, maternal healthcare services utilization is far below the recommended level in Ethiopia with a high urban-rural disparity. Currently, two-thirds of pregnant women do not receive the recommended number of antenatal care, more than 50% of births are not attended by skilled birth attendants, and two-thirds of postpartum women do not receive postnatal checks, according to the 2019 EDHS report. There is also evidence that the rate of continuity of maternity care completion is low, implying that pregnant women are not getting the most out of the existing healthcare services. In Ethiopia, the rural communities are scattered over a wide geographic area some with difficult mountains and valleys. Hence, geographic barriers and limited information sources are likely to influence women's access to skilled birth attendance. As part of improving access and overcoming physical or geographical inaccessibility in rural areas, maternity waiting homes; residential lodgings built near healthcare facilities where expectant women near or at term would stay till the onset of labor is one of the measures taken by the Ethiopian government. The majority of the rural populations commonly have a lower perception of health services in general, and many traditional practices support behaviors that are inconsistent with effective health interventions. Thus, there is a challenge concerning behavior (social norms, beliefs, and culture) from the demand side related to utilizing maternity services on top of non/partial functionality of existing waiting homes. Therefore, this research project aimed at promoting access to and utilization of maternal healthcare services utilization in southern Ethiopia.

详细描述

Health centers and kebeles (villages) in the study setting were randomly assigned to intervention or comparison. We recruited all eligible pregnant women who reside in the respective selected health centres' catchment areas. In the intervention areas, community health workers (unpaid and volunteer women) were identified in consultation with the head of the villages/local leaders/. They received training on safe motherhood, the benefit and importance of maternity homes, identification of local beliefs, traditions and taboos that are barriers to birth preparation, stay in maternity homes and the use of maternal health services. The main functions of these trained community health worker in the intervention clusters include facilitating training sessions for pregnant women, assisting pregnant women in the preparation of birth preparedness plan, supporting pregnant women in starting and sustaining maternity care (prenatal care, skilled delivery and postnatal care). Pregnant women were also trained in the intervention clusters (12 sessions/4 sessions per cluster).

The training of both community health workers and pregnant women was based on a video story titled "Why Did Mr. X Die, Retold?" and a manual on working with individuals, families and communities to improve maternal and neonatal health from the World Health Organization.

After getting permission from the World Health Organization to use the video, we translated it into the local language and used it as an introduction during training. The training was designed based on the findings of preliminary studies and was intended to educate pregnant women about danger signs during pregnancy, labour and the postpartum period, about the birth preparation plan, the benefits and importance of waiting homes. In addition, it also covered how to develop a birth plan that included waiting home with the help of community health workers, as well as correcting misconceptions (belief-related barriers). The intervention was based on principles from the theory of planned behavior and the health belief model. These models were considered to offer direction for what types of variables and processes may be important in shaping maternal health behaviors and thus needed to be addressed in the intervention. The theory of planned behavior is used to explain and predict behavior based on attitudes, norms, and intentions and stipulates that an individual intention to act (behavior) is essentially a function of that individual's attitude toward that behavior and perceptions of social subjective norms. The health belief model which describes how health beliefs interact with modifying factors (e.g., perceived seriousness of problem) to determine health behaviors was also considered in developing the intervention.

The comparison group continued to receive maternal health information and services that are provided as part of the routine healthcare system. Both the baseline and end-line data were managed by trained interviewers using a mobile application supporting Open Data Kit. Data were analyzed through descriptive and inferential statistics (Chi-square test, McNemar tests and multi-level mixed-effects logistic regression analysis). For all analyses, a p-value of <0.05 was considered the level of significance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Those who had resided for at least six months in the selected kebele clusters and had given birth in the five years preceding the survey were included to maintain homogeneity of information exposure. Another criterion for inclusion was a maximum gestational age of 27 weeks (end of second trimester) as participants were required to attend at least two sessions of the proposed promotional intervention before their due date.

排除标准

  • •Those who met the inclusion criteria but were critically ill at the time of enrolment and/or those who were reluctant to participate were excluded.

研究组 & 干预措施

Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading

Experimental
  1. Improving the quality of maternal health services in health centers (training for midwives in basic emergency obstetric care and upgrading maternity waiting homes to the level to provide basic accommodation to address access-related barriers
  2. Training community health workers with the aim of improving their knowledge about safe motherhood and about how to prepare a birth plan, including stays in maternity waiting homes
  3. Training pregnant women

干预措施: Safe motherhood Promotion (Behavioral)

Comparison

No Intervention

The current standard service package

结局指标

主要结局

health facility visits after childbirth (postnatal care use)

时间窗: through study completion, an average of 9 months

Having visited postnatal clinic after delivery

the location of the delivery (home vs. health facility)

时间窗: through study completion, an average of 9 months

institutional birth was used to indicate skilled birth attendance as trained health workers do not conduct deliveries outside of health facilities in these areas.

次要结局

  • birth preparedness practice(through study completion, an average of 9 months)
  • knowledge of obstetric danger signs(through study completion, an average of 9 months)

研究者

发起方
Prof Yves Jacquemyn
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof Yves Jacquemyn

Professor

Universiteit Antwerpen

研究点 (1)

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