- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775150
Saving Mother and Baby With Text Messaging
Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H8L6
- Ottawa Hospital Research Institue
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women who were registered by local Maternal Child Health unit during the study period
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: health education
health education via text messaging
|
Health education via text messaging
|
No Intervention: no health education
no health education via text messaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal death
Time Frame: 28 days
|
28 days after birth
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal death
Time Frame: 300 days
|
From conception to 42 days postpartum
|
300 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rihua Xie, PhD, Ottawa Hospital Research Institute
- Study Director: Shi Wu Wen, PhD, Ottawa Hospital Resarch Institute
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0029-01-04-01-01
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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