BleedingNCT01775150
Saving Mother and Baby With Text Messaging
A study testing health education in people with Bleeding and Infection, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Bleeding, Infection, Malnutrition
- What is being tested?
- health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,646 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women who were registered by local Maternal Child Health unit during the study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
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.
Read the detailed description
- 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.
- 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.
- 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
- Bleeding, Infection, Malnutrition, Complications
- Being tested
- health education
- Keywords
- mobile phone text messaging, maternality, infant, death rate
- Medical subject headings
- Hemorrhage, Infections, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationOther
Health education via text messaging
| Study group | Role | What they receive |
|---|---|---|
| health education | Experimental | health education via text messaging Receives: Other: health education |
| no health education | No intervention | no health education via text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal death
28 days after birth
Measured: 28 days
Secondary outcomes (1)
Maternal death
From conception to 42 days postpartum
Measured: 300 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startOct 2011
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,646 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian International Development Agency, Canadian Institutes of Health Research (CIHR), Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Rihua Xie, PhD, Principal investigator, Ottawa Hospital Research InstituteShi Wu Wen, PhD, Study director, Ottawa Hospital Resarch Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775150
- Sponsor's protocol ID
- 0029-01-04-01-01
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32813276Xie 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.
PubMed 30567693
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
- ClinicalTrials.gov ID
- NCT01775150
- Acronym / sponsor ID
- 0029-01-04-01-01
- Conditions
- Bleeding, Infection, Malnutrition, Complications
- Keywords
- mobile phone text messaging, maternality, infant, death rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,646 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian International Development Agency, Canadian Institutes of Health Research (CIHR), Bill and Melinda Gates Foundation
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health education | Experimental | Other: health educationhealth education via text messaging |
| no health education | No intervention | –no health education via text messaging |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- women who were registered by local Maternal Child Health unit during the study period
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health educationHealth education via text messaging | Other | health education |
Primary outcome
Neonatal death
Time frame: 28 days
28 days after birth
1 secondary outcome
Maternal death
Time frame: 300 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Derived from this study: PubMed 32813276Palmer 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.
- Derived from this study: PubMed 30567693Xie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rihua Xie, PhD principal investigator
Ottawa Hospital Research Institute
Shi Wu Wen, PhD study director
Ottawa Hospital Resarch Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education in people with Bleeding and Infection, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal death (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775150, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.