Saving Mother and Baby With Text Messaging
Primary Purpose
Bleeding, Infection, Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
health education
Sponsored by
About this trial
This is an interventional health services research trial for Bleeding focused on measuring mobile phone text messaging, maternality, infant, death rate
Eligibility Criteria
Inclusion Criteria:
- women who were registered by local Maternal Child Health unit during the study period
Exclusion Criteria:
Sites / Locations
- Ottawa Hospital Research Institue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
health education
no health education
Arm Description
health education via text messaging
no health education via text messaging
Outcomes
Primary Outcome Measures
Neonatal death
28 days after birth
Secondary Outcome Measures
Maternal death
From conception to 42 days postpartum
Full Information
NCT ID
NCT01775150
First Posted
January 22, 2013
Last Updated
January 22, 2013
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian International Development Agency, Canadian Institutes of Health Research (CIHR), Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01775150
Brief Title
Saving Mother and Baby With Text Messaging
Official Title
Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian International Development Agency, Canadian Institutes of Health Research (CIHR), Bill and Melinda Gates Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We plan to integrate WHO educational material using mobile phone text messaging, target on pregnant women in remote rural areas in China. We hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural China because text messaging is accessible, acceptable, and affordable.
Detailed Description
Sampling method:
Random sampling method will be used. Counties in Huaihua area of Chinese province of Hunan will be randomly allocated to intervention and non-intervention groups.
The intervention:
Mobile phone text messages containing maternal and newborn health care education material will be sent to mothers-to-be at the first, second and third trimester, and again postpartum period.
Statistical analysis:
We will first compare the baseline characteristics (including the average income, adult educational level, and maternal and perinatal mortality rates in the past two years) between the 2 arms of experiment. For costs data, total costs, costs per participating woman, and costs per maternal/infant death avoided will be reported. For primary outcomes, we will determine and report rate ratios, risk differences, and numbers needed to treat (NNT) from the experimental arm (i.e., mobile phone text messaging), using the usual care arm (no text messaging) as the reference. Relative risks and 95% confidence intervals will be expressed as the effect measures. We will estimate the adjusted relative risks and 95% confidence intervals by regression analysis. Mixed models taking consideration of multi-level measures (e.g., mortality and morbidity measured at individual level and intervention measured at village level) will be used in the regression analysis (Donner and Klar, 2000).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Infection, Malnutrition, Complications
Keywords
mobile phone text messaging, maternality, infant, death rate
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5646 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
health education
Arm Type
Experimental
Arm Description
health education via text messaging
Arm Title
no health education
Arm Type
No Intervention
Arm Description
no health education via text messaging
Intervention Type
Other
Intervention Name(s)
health education
Intervention Description
Health education via text messaging
Primary Outcome Measure Information:
Title
Neonatal death
Description
28 days after birth
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Maternal death
Description
From conception to 42 days postpartum
Time Frame
300 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women who were registered by local Maternal Child Health unit during the study period
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rihua Xie, PhD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shi Wu Wen, PhD
Organizational Affiliation
Ottawa Hospital Resarch Institute
Official's Role
Study Director
Facility Information:
Facility Name
Ottawa Hospital Research Institue
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
12. IPD Sharing Statement
Citations:
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
PubMed Identifier
30567693
Citation
Xie RH, Tan H, Taljaard M, Liao Y, Krewski D, Du Q, Wen SW. The Impact of a Maternal Education Program Through Text Messaging in Rural China: Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Dec 19;6(12):e11213. doi: 10.2196/11213.
Results Reference
derived
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Saving Mother and Baby With Text Messaging
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