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

September 3, 2018 updated by: Krissada Tomyabatra, Nopparatrajathanee Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10230
        • Nopparatrajathanee Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: social networking on mobile phone
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
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: no social networking on mobile phone
usual antenatal care group-health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Premature birth
Time Frame: before 37 weeks gestation
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
Time Frame: 28 days after birth
Respiratory distress syndrome (RDS) is a breathing disorder that affects newborns [NIH]
28 days after birth
Rate of Stillbirth
Time Frame: after 28 weeks' gestation to birth
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
Time Frame: after 28 weeks' gestation to the first week of life [WHO]
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nopparatrajathanee Hospital

Investigators

  • Principal Investigator: Krissada Tomyabatra, MD, RTCOG, Nopparatrajathanee Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HISONET-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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