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临床试验/NCT03145155
NCT03145155已完成不适用

Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children: a Cluster Randomized Control Trial in Myanmar

Tokyo University1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2017年5月22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
630
试验地点
1
主要终点
Completion of continuum of care

研究概览

简要总结

The objectives of this cluster randomized control trial are to examine the effect of combined intervention of the utilization of continuum of care (CoC) card and health education on the completion of CoC services among mothers and to examine the effect of health education on NCDs and nutrition on mothers' knowledge on NCDs and nutrition in Myanmar. Pregnant women between 12-20 weeks of pregnancy will be recruited and assigned into intervention arm (n=600) and control arm (n=600). The intervention package will comprise of two components, (1) utilization of CoC card and (2) health education on CoC in maternal, newborn and child health (MNCH), NCD and nutrition. The CoC card will include CoC services from first antenatal care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and four PNC and essential services. Pregnant women will get stickers if they receive above services. Health education will be given three times during pregnancy and one time during postpartum period. Health education will include importance of continuous uptake of MNCH services, NCDs and nutrition. The outcomes are proportion of completion of CoC services and knowledge on NCDs and nutrition.

详细描述

Antenatal care (ANC) is an important entry point for subsequent use of delivery and postnatal care (PNC) services. When women receive high-quality ANC, they will have skilled birth attendant (SBA) at delivery and continue to receive postnatal care. Continuous uptake of above services is necessary to improve health and well being of maternal, newborn and child health (MNCH). Moreover, the continuum of Care (CoC) offers the critical entry point for women and children for preventive care and health promotion on noncommunicable diseases (NCDs). ANC and PNC visits for women and a series of immunization for children are crucial opportunities to provide integrated services of NCDs. The integration of NCDs prevention and control programs in MNCH services would empower women to control NCDs in their families. However, no study has examined the effect of antenatal health education on CoC on completion of CoC among mothers in Myanmar. In addition, no study has examined the effect of antenatal health education on NCDs and nutrition on knowledge on NCDs and nutrition, and on maternal complications among mothers in Myanmar.

A cluster randomized controlled trial will be done among pregnant women living in study area. The unit of randomization in this study will be "rural health center (RHC)". In each RHC, there are at least four Sub-centers (SCs). RHC including SCs will be considered as one cluster. The investigators will advocate midwives (MW) on the CoC in MNCH and introduce the CoC card. The investigators will also recruit and train Public Health Supervisors 2 (PHS2) in each cluster to provide health education to pregnant women on CoC in MNCH, NCDs and nutrition.

We will conduct the study in three townships (Pantanaw, Inapu, Wakema,) in Ayeyarwaddy region, Myanmar from May 2017 to March 2018. There are a total of 22 health facilities. Out of 22 health facilities in 3 townships, eleven will be allocated into intervention arm and another 11 into control arm. An analyst, who will not be a primary member of the study team, will conduct randomization of clusters using computer-generated random sequences. Estimated sample size of 1200 pregnant women will be recruited, roughly 400 pregnant women in each township. The investigators estimate that about 28 women will seek ANC within one month in each cluster. In total of 22 clusters, the investigators estimate 600 women will seek ANC within one month; therefore, the enrollment period will take two months to get the targeted sample size of 1,200 pregnant women.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women
  • 18 years and above
  • between 12-20 weeks of pregnancy at the time of first ANC

排除标准

  • younger than 18 years
  • first ANC before 12 weeks or after 20 weeks
  • mentally ill
  • migrant and mobile people

研究组 & 干预措施

Intervention

Experimental

Pregnant women in intervention arm will receive CoC card and health education on CoC in maternal, newborn and child health (MNCH), NCD and nutrition. The CoC card will include CoC services from first antenatal care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and four PNC and essential services. Pregnant women will get stickers if they receive above services. Health education will be given three times during pregnancy and one time during postpartum period.

干预措施: Integrating services for noncommunicable diseases in continuum of care for mothers and children (Behavioral)

Control

Placebo Comparator

Pregnant women in control arm will receive ordinary health education on pregnancy care

干预措施: Ordinary health education for pregnant women (Behavioral)

结局指标

主要结局

Completion of continuum of care

时间窗: 3 months after delivery

Proportion of mothers who complete four antenatal care visits, skilled birth attendance and four postnatal care visits

次要结局

  • Change in knowledge on NCDs and nutrition(Baseline and 3 months after delivery)

研究者

发起方
Tokyo University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Moe Moe Thandar

PhD candidate, Department of Community and Global Health, School of International Health, Graduate School of Medicine

Tokyo University

研究点 (1)

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