Saving Mother and Baby With Text Messaging

Malnutrition Clinical Trial

Official title:

Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01775150
• Other study ID #: 0029-01-04-01-01
• Status: Active, not recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: January 22, 2013
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2013
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5646
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bleeding
• Complications
• Infection
• Malnutrition

Intervention

Other:
• health education
Health education via text messaging

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institue	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Bill and Melinda Gates Foundation, Canadian Institutes of Health Research (CIHR), Canadian International Development Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal death	28 days after birth	28 days	No
Secondary	Maternal death	From conception to 42 days postpartum	300 days	No