Saving Mother and Baby With Text Messaging

NCT ID: NCT01775150

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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).

Conditions

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Bleeding Infection Malnutrition Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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health education

health education via text messaging

Group Type EXPERIMENTAL

health education

Intervention Type OTHER

Health education via text messaging

no health education

no health education via text messaging

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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health education

Health education via text messaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian International Development Agency

OTHER_GOV

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rihua Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Shi Wu Wen, PhD

Role: STUDY_DIRECTOR

Ottawa Hospital Resarch Institute

Locations

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Ottawa Hospital Research Institue

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32813276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30567693 (View on PubMed)

Other Identifiers

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0029-01-04-01-01

Identifier Type: -

Identifier Source: org_study_id

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