Clinical trial NCT02371213: Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Social Networking
Mobile phone
Antenatal Care
Health education
Maternal outcome
Neonatal outcome
Lead sponsor: Nopparatrajathanee Hospital
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 1160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Premature birth
timeFrame: before 37 weeks gestation
Secondary outcomes:
measure: Rate of Respiratory Distress Syndrome
timeFrame: 28 days after birth
measure: Rate of Stillbirth
timeFrame: after 28 weeks' gestation to birth
measure: Rate of Perinatal Mortality
timeFrame: after 28 weeks' gestation to the first week of life [WHO]
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Nopparatrajathanee Hospital
Study officials:
affiliation: Nopparatrajathanee Hospital
name: Krissada Tomyabatra, MD, RTCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
citation: Beck S, Wojdyla D, Say L, Betran AP, Merialdi M, Requejo JH, Rubens C, Menon R, Van Look PF. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010 Jan;88(1):31-8. doi: 10.2471/BLT.08.062554. Epub 2009 Sep 25.
citation: Jareethum R, Titapant V, Chantra T, Sommai V, Chuenwattana P, Jirawan C. Satisfaction of healthy pregnant women receiving short message service via mobile phone for prenatal support: A randomized controlled trial. J Med Assoc Thai. 2008 Apr;91(4):458-63.
citation: Lund S, Hemed M, Nielsen BB, Said A, Said K, Makungu MH, Rasch V. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial. BJOG. 2012 Sep;119(10):1256-64. doi: 10.1111/j.1471-0528.2012.03413.x. Epub 2012 Jul 17.
citation: Lund S, Nielsen BB, Hemed M, Boas IM, Said A, Said K, Makungu MH, Rasch V. Mobile phones improve antenatal care attendance in Zanzibar: a cluster randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 17;14:29. doi: 10.1186/1471-2393-14-29.
citation: Lund S, Rasch V, Hemed M, Boas IM, Said A, Said K, Makundu MH, Nielsen BB. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial. JMIR Mhealth Uhealth. 2014 Mar 26;2(1):e15. doi: 10.2196/mhealth.2941.
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.