This trial is active, not recruiting.

Conditions bleeding, infection, malnutrition, complications
Treatment health education
Sponsor Ottawa Hospital Research Institute
Collaborator Canadian International Development Agency
Start date October 2011
End date March 2013
Trial size 5646 participants
Trial identifier NCT01775150, 0029-01-04-01-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
health education via text messaging
health education
Health education via text messaging
(No Intervention)
no health education via text messaging

Primary Outcomes

Neonatal death
time frame: 28 days

Secondary Outcomes

Maternal death
time frame: 300 days

Eligibility Criteria

Female participants from 16 years up to 45 years old.

Inclusion Criteria: - women who were registered by local Maternal Child Health unit during the study period Exclusion Criteria:

Additional Information

Official title Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Principal investigator Rihua Xie, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.