Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes

Premature Birth Clinical Trial

— HISONET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371213
• Other study ID #: HISONET-1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Nopparatrajathanee Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• 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

Locations

Country	Name	City	State
Thailand	Nopparatrajathanee Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Nopparatrajathanee Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. Review. — View 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. — View 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. Erratum in: Lancet. 2016 Jun 18;387(10037):2506. Erratum in: Lancet. 2015 Jan 31;385(9966):420. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Premature birth	Preterm is defined as babies born alive before 37 weeks of pregnancy are completed [WHO]	before 37 weeks gestation
Secondary	Rate of Respiratory Distress Syndrome	Respiratory distress syndrome (RDS) is a breathing disorder that affects newborns [NIH]	28 days after birth
Secondary	Rate of Stillbirth	A baby born with no signs of life at or after 28 weeks' gestation [WHO]	after 28 weeks' gestation to birth
Secondary	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]