Saving Mother and Baby With Text Messaging
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|ClinicalTrials.gov Identifier: NCT01775150|
Recruitment Status : Unknown
Verified January 2013 by Ottawa Hospital Research Institute.
Recruitment status was: Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bleeding Infection Malnutrition Complications||Other: health education||Not Applicable|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5646 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||May 2013|
Experimental: health education
health education via text messaging
Other: health education
Health education via text messaging
No Intervention: no health education
no health education via text messaging
- Neonatal death [ Time Frame: 28 days ]28 days after birth
- Maternal death [ Time Frame: 300 days ]From conception to 42 days postpartum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775150
|Ottawa Hospital Research Institue|
|Ottawa, Ontario, Canada, K1H8L6|
|Principal Investigator:||Rihua Xie, PhD||Ottawa Hospital Research Institute|
|Study Director:||Shi Wu Wen, PhD||Ottawa Hospital Resarch Institute|