Clinical trial NCT01775150: Saving Mother and Baby With Text Messaging
Official title: Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bleeding
Infection
Malnutrition
Complications
Keywords: mobile phone text messaging
maternality
infant
death rate
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian International Development Agency
name: Canadian Institutes of Health Research (CIHR)
name: Bill and Melinda Gates Foundation
First posted: 2013-01-24
Enrollment: 5646
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Neonatal death
timeFrame: 28 days
Secondary outcomes:
measure: Maternal death
timeFrame: 300 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institue
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Rihua Xie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Resarch Institute
name: Shi Wu Wen, PhD
role: STUDY_DIRECTOR
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Xie RH, Tan H, Taljaard M, Liao Y, Krewski D, Du Q, Wen SW. The Impact of a Maternal Education Program Through Text Messaging in Rural China: Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Dec 19;6(12):e11213. doi: 10.2196/11213.