Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Other: social networking on mobile phone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: social networking on mobile phone<br>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 | Other: social networking on mobile phone<br>* Audio-video media about serious complications such as labor pain, vaginal bleeding, water breaking and fewer fetal movement via social networking application on mobile phone to antenatal women from the first ANC visit four times every month and four times biweekly<br>|
| No Intervention: no social networking on mobile phone<br>usual antenatal care group-health education | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Premature birth | Preterm is defined as babies born alive before 37 weeks of pregnancy are completed [WHO] | before 37 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Respiratory Distress Syndrome | Respiratory distress syndrome (RDS) is a breathing disorder that affects newborns [NIH] | 28 days after birth | 
| Rate of Stillbirth | A baby born with no signs of life at or after 28 weeks' gestation [WHO] | after 28 weeks' gestation to birth | 
| Rate of Perinatal Mortality | Perinatal mortality refers to the number of stillbirths and deaths in the first week of life (early neonatal mortality). [WHO] | after 28 weeks' gestation to the first week of life [WHO] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Networking, Mobile phone, Antenatal Care, Health education, Maternal outcome, Neonatal outcome