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Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes (HISONET)

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
social networking on mobile phone
Sponsored by
Nopparatrajathanee Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Social Networking, Mobile phone, Antenatal Care, Health education, Maternal outcome, Neonatal outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nopparatrajathanee Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

social networking on mobile phone

no social networking on mobile phone

Arm Description

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

usual antenatal care group-health education

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2015
Last Updated
September 3, 2018
Sponsor
Nopparatrajathanee Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02371213
Brief Title
Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nopparatrajathanee Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Social Networking, Mobile phone, Antenatal Care, Health education, Maternal outcome, Neonatal outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
social networking on mobile phone
Arm Type
Experimental
Arm Description
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
Arm Title
no social networking on mobile phone
Arm Type
No Intervention
Arm Description
usual antenatal care group-health education
Intervention Type
Other
Intervention Name(s)
social networking on mobile phone
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of Premature birth
Description
Preterm is defined as babies born alive before 37 weeks of pregnancy are completed [WHO]
Time Frame
before 37 weeks gestation
Secondary Outcome Measure Information:
Title
Rate of Respiratory Distress Syndrome
Description
Respiratory distress syndrome (RDS) is a breathing disorder that affects newborns [NIH]
Time Frame
28 days after birth
Title
Rate of Stillbirth
Description
A baby born with no signs of life at or after 28 weeks' gestation [WHO]
Time Frame
after 28 weeks' gestation to birth
Title
Rate of Perinatal Mortality
Description
Perinatal mortality refers to the number of stillbirths and deaths in the first week of life (early neonatal mortality). [WHO]
Time Frame
after 28 weeks' gestation to the first week of life [WHO]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krissada Tomyabatra, MD, RTCOG
Organizational Affiliation
Nopparatrajathanee Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nopparatrajathanee Hospital
City
Bangkok
ZIP/Postal Code
10230
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25280870
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. 2015 Jan 31;385(9966):420. Lancet. 2016 Jun 18;387(10037):2506.
Results Reference
background
PubMed Identifier
20428351
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.
Results Reference
background
PubMed Identifier
18556852
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.
Results Reference
background
PubMed Identifier
22805598
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.
Results Reference
background
PubMed Identifier
24438517
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.
Results Reference
background
PubMed Identifier
25098184
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.
Results Reference
background
PubMed Identifier
32813276
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.
Results Reference
derived

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Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes

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