Saving Mother and Baby With Text Messaging

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01775150
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Bleeding
Infection
Malnutrition
Complications
Other: health education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Neonatal death [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    28 days after birth


Secondary Outcome Measures:
  • Maternal death [ Time Frame: 300 days ] [ Designated as safety issue: No ]
    From conception to 42 days postpartum


Estimated Enrollment: 5646
Study Start Date: October 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders 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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01775150     History of Changes
Other Study ID Numbers: 0029-01-04-01-01
Study First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Hemorrhage
Malnutrition
Pathologic Processes
Nutrition Disorders

ClinicalTrials.gov processed this record on July 28, 2014