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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
Sponsor:
Collaborators:
Canadian International Development Agency
Canadian Institutes of Health Research (CIHR)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Bleeding Infection Malnutrition Complications Other: health education Not Applicable

Detailed Description:
  1. 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.

  2. 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.

  3. 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
Allocation: Randomized
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Neonatal death [ Time Frame: 28 days ]
    28 days after birth


Secondary Outcome Measures :
  1. Maternal death [ Time Frame: 300 days ]
    From conception to 42 days postpartum



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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women who were registered by local Maternal Child Health unit during the study period

Exclusion Criteria:


Information from the National Library of Medicine

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


Locations
Canada, Ontario
Ottawa Hospital Research Institue
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian International Development Agency
Canadian Institutes of Health Research (CIHR)
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Rihua Xie, PhD Ottawa Hospital Research Institute
Study Director: Shi Wu Wen, PhD Ottawa Hospital Resarch Institute

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01775150     History of Changes
Other Study ID Numbers: 0029-01-04-01-01
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Ottawa Hospital Research Institute:
mobile phone text messaging
maternality
infant
death rate

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders