Overview

This trial is active, not recruiting.

Condition premature birth
Treatment social networking on mobile phone
Sponsor Nopparatrajathanee Hospital
Start date April 2015
End date July 2017
Trial size 1160 participants
Trial identifier NCT02371213, HISONET-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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
social networking on mobile phone
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
(No Intervention)
usual antenatal care group-health education

Primary Outcomes

Measure
Rate of Premature birth
time frame: before 37 weeks gestation

Secondary Outcomes

Measure
Rate of Respiratory Distress Syndrome
time frame: 28 days after birth
Rate of Stillbirth
time frame: after 28 weeks' gestation to birth
Rate of Perinatal Mortality
time frame: after 28 weeks' gestation to the first week of life [WHO]

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial
Principal investigator Krissada Tomyabatra, MD, RTCOG
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Nopparatrajathanee Hospital.