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临床试验/NCT02371213
NCT02371213已完成不适用

Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial

Nopparatrajathanee Hospital2 个研究点 分布在 1 个国家目标入组 1,160 人开始时间: 2015年4月1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
入组人数
1,160
试验地点
2
主要终点
Rate of Premature birth

研究概览

简要总结

The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.

详细描述

Health Education Intervention with Social Networking (HISONET) is a open-label randomized controlled trial. The objective of this study is to determine the efficacy of social networking media on mobile phone intervention in antenatal care (ANC) group-health education compared with usual ANC health education. The incidence of preterm delivery and major neonatal morbidity including respiratory distress syndrome, stillbirth and perinatal mortality in women delivering from 28 to 36 weeks' gestation are significant outcomes in a randomized prospective design. Preterm delivery occurs in approximately 9.6% as global incidence, and about 11.1% in South-Eastern Asia. Forty-four percent of child under 5 years died in neonatal period. Preterm birth is one of the three leading causes of neonatal death which 15% died from preterm birth complications such as respiratory distress syndrome, intraventricular hemorrhage, necrotizing entercolitis, and sepsis. Recent studies demonstrate that Short Message Service (SMS) on mobile phone intervention in antenatal care can increase numbers of ANC attendance to WHO recommendation of four or more visits and decrease in perinatal mortality.

Social networking on mobile phone has been increasingly used in daily life of both healthcare personnel and women who attend ANC clinic. However, there is lack of evidence that demonstrates the effect of social networking on mobile phone to improve maternal and neonatal outcomes. LINE, a mobile application, is a popular one of many social networking applications. So, health education through LINE of antenatal women about serious complications such as labor pain, bleeding, water breaking and fewer fetal movement during pregnancy may encourage them to come to the hospital as early as possible. Early diagnosis of premature labor provides early management and better maternal and neonatal outcomes. So, a randomized controlled trial should be conducted to answer these questions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • women who attend antenatal care clinic and have intention to deliver at the study hospital.
  • Thai race
  • participant or husband or relatives is an owner of mobile phone with social networking application

排除标准

  • participant is known by other one in different study arm (contamination)
  • cannot be assess on wel-being about privacy, delivery failure and misinterpretation of media via social network after complete study

研究组 & 干预措施

social networking on mobile phone

Experimental

Audio-video media via social networking on mobile phone to antenatal women from the first ANC visit four times every month and four times biweekly plus usual antenatal care group-health education

干预措施: social networking on mobile phone (Other)

no social networking on mobile phone

No Intervention

usual antenatal care group-health education

结局指标

主要结局

Rate of Premature birth

时间窗: before 37 weeks gestation

Preterm is defined as babies born alive before 37 weeks of pregnancy are completed \[WHO\]

次要结局

  • Rate of Respiratory Distress Syndrome(28 days after birth)
  • Rate of Stillbirth(after 28 weeks' gestation to birth)
  • Rate of Perinatal Mortality(after 28 weeks' gestation to the first week of life [WHO])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Krissada Tomyabatra

Dr

Nopparatrajathanee Hospital

研究点 (2)

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