NCT02371213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

3.4 years

First QC Date

February 19, 2015

Last Update Submit

September 3, 2018

Conditions

Keywords

Social NetworkingMobile phoneAntenatal CareHealth educationMaternal outcomeNeonatal outcome

Outcome Measures

Primary Outcomes (1)

  • Rate of Premature birth

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

    before 37 weeks gestation

Secondary Outcomes (3)

  • Rate of Respiratory Distress Syndrome

    28 days after birth

  • Rate of Stillbirth

    after 28 weeks' gestation to birth

  • Rate of Perinatal Mortality

    after 28 weeks' gestation to the first week of life [WHO]

Study Arms (2)

social networking on mobile phone

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

Other: social networking on mobile phone

no social networking on mobile phone

NO INTERVENTION

usual antenatal care group-health education

Interventions

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

social networking on mobile phone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nopparatrajathanee Hospital

Bangkok, 10230, Thailand

Location

Related Publications (7)

  • 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.

    PMID: 25280870BACKGROUND
  • 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.

    PMID: 20428351BACKGROUND
  • 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.

    PMID: 18556852BACKGROUND
  • 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.

    PMID: 22805598BACKGROUND
  • 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.

    PMID: 24438517BACKGROUND
  • 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.

    PMID: 25098184BACKGROUND
  • 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.

MeSH Terms

Conditions

Premature BirthHealth Education

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Krissada Tomyabatra, MD, RTCOG

    Nopparatrajathanee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

April 1, 2015

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations