PregnancyNCT01821222
Wired Mothers - Use of Mobile Phones to Improve Maternal and Neonatal Health in Zanzibar
A study testing Wired mothers in people with Pregnancy and Maternal Health, run by University of Copenhagen at 1 site in Tanzania.
Trial summary
Reducing maternal and newborn mortality remains a global challenge. Because obstetric complications cannot be predicted, skilled attendance at the time of delivery and access to emergency obstetric care remain the most effective strategies to reduce mortality. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Pregnancy, Maternal Health, Newborn Death
- What is being tested?
- Wired mothers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,550 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2009to Apr 2010
- 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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women attending antenatal care at one of 24 selected primary healthcare facilities
Who cannot join
- Missing end-of-study questionnaire
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
24 Primary Healthcare Facilities on the island on Unguja
Zanzibar
About this study
Official title: Mobile Phones as a Health Communication Tool to Improve Maternal and Neonatal Health in Zanzibar
Reducing maternal and newborn mortality remains a global challenge. Because obstetric complications cannot be predicted, skilled attendance at the time of delivery and access to emergency obstetric care remain the most effective strategies to reduce mortality. Antenatal care has the potential to reduce maternal morbidity and improve newborns survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. There is a rapidly expanding number of mobile phone users in developing countries and due to the potential to strengthen health system the use of mobile phones is health care is emerging. The investigators assessed a mobile phone intervention named "wired mothers" aimed to improve maternal and newborn health.
The hypothesis of the study was that the wired mothers mobile phone intervention would increase attendance to essential reproductive health services such as antenatal care and skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and newborn.
Read more
The objective of the study was to examine the effect of the wired mothers intervention on antenatal care, skilled delivery attendance, access to emergency obstetric care and perinatal mortality.
The study was a pragmatic cluster randomized controlled trial with the primary health care facility as the unit of randomization. The study took place in 2009-2010 on the island of Unguja in Zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected facilities were included at their first visit and followed until 42 days after delivery. Facilities were allocated by simple randomization to either mobile phone intervention (n=12) or standard care (n=12). The intervention consisted of a SMS and mobile phone voucher component.
The perspectives of the study are that mobile phones may contribute to saving the lives of women and their newborns and achievement of MDGs 4 and 5. Evidence is needed to guide maternal and child health policy makers in developing countries.
- Conditions
- Pregnancy, Maternal Health, Newborn Death, Health Behavior, mHealth
- Being tested
- Wired mothers
- Keywords
- Maternal health, Neonatal health, mHealth, Mobile phones, Access to health services, Health behavior
- Medical subject headings
- Perinatal Death, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wired mothersDevice
The wired mothers SMS component provided health education and appointment reminders to encourage attendance at routine antenatal care, skilled delivery attendance and postnatal care. A specially-designed software automatically generated and sent text messages throughout the pregnancy until six weeks after delivery. The frequency and content of the messages varied according to the women's gestational age.
Mobile phone vouchers allowed all wired mothers to communicate directly with primary health care providers. Primary health care facilities randomised for intervention and hospitals were provided with a mobile phone with sufficient credit, while wired mothers were given a phone voucher with modest credit and a card with the phone number of her local primary health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Wired mothers intervention | Experimental | The wired mothers' intervention consisted of two components: an automated short messaging service (SMS) system providing wired mothers with unidirectional text messaging and a mobile phone voucher system providing the possibility of direct two-way communication between wired mothers and their primary health care providers. While only women with registered phone numbers received text messages, all women in the intervention group were given mobile phone vouchers to contact their local primary health care provider. Receives: Device: Wired mothers |
| Control | No intervention | The control group received standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skilled delivery attendance
We used the WHO definition, whereby skilled delivery attendants are midwifes, doctors or nurses who have been educated and trained in the skills needed to manage pregnancies, childbirth and complications in women and newborns. We also included home deliveries assisted by skilled birth attendants, although international consensus has not been reached on this issue.
Measured: From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery
Secondary outcomes (2)
Perinatal mortality
Calculated as a composite of stillbirths and early neonatal deaths
Measured: From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery
Antenatal care attendance
Measured: From inclusion of the pregnant women until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- 2,550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Welfare, Zanzibar, Danish International Development Cooperation
- Responsible party
- Principal investigator, Stine Lund, MD, PhD fellow, University of Copenhagen
- Investigators
- Stine Lund, MD, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821222
- Sponsor's protocol ID
- 09-086KU
- Status last verified
- Mar 2013
- First submitted
- 26 Mar 2013
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lund S, Hemed M, Nielsen BB, Said A, Said K, Makungu MH, Rasch V. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial. BJOG. 2012 Sep;119(10):1256-64. doi: 10.1111/j.1471-0528.2012.03413.x. Epub 2012 Jul 17.
PubMed 22805598Lund S, Rasch V, Hemed M, Boas IM, Said A, Said K, Makundu MH, Nielsen BB. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial. JMIR Mhealth Uhealth. 2014 Mar 26;2(1):e15. doi: 10.2196/mhealth.2941.
PubMed 25098184Lund S, Nielsen BB, Hemed M, Boas IM, Said A, Said K, Makungu MH, Rasch V. Mobile phones improve antenatal care attendance in Zanzibar: a cluster randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 17;14:29. doi: 10.1186/1471-2393-14-29.
PubMed 24438517
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phones as a Health Communication Tool to Improve Maternal and Neonatal Health in Zanzibar
- ClinicalTrials.gov ID
- NCT01821222
- Acronym / sponsor ID
- 09-086KU
- Conditions
- Pregnancy, Maternal Health, Newborn Death, Health Behavior, mHealth
- Keywords
- Maternal health, Neonatal health, mHealth, Mobile phones, Access to health services, Health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,550 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Welfare, Zanzibar, Danish International Development Cooperation
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Mar 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.
Reducing maternal and newborn mortality remains a global challenge. Because obstetric complications cannot be predicted, skilled attendance at the time of delivery and access to emergency obstetric care remain the most effective strategies to reduce mortality. Antenatal care has the potential to reduce maternal morbidity and improve newborns survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. There is a rapidly expanding number of mobile phone users in developing countries and due to the potential to strengthen health system the use of mobile phones is health care is emerging. The investigators assessed a mobile phone intervention named "wired mothers" aimed to improve maternal and newborn health.
The hypothesis of the study was that the wired mothers mobile phone intervention would increase attendance to essential reproductive health services such as antenatal care and skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and newborn.
The objective of the study was to examine the effect of the wired mothers intervention on antenatal care, skilled delivery attendance, access to emergency obstetric care and perinatal mortality.
The study was a pragmatic cluster randomized controlled trial with the primary health care facility as the unit of randomization. The study took place in 2009-2010 on the island of Unguja in Zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected facilities were included at their first visit and followed until 42 days after delivery. Facilities were allocated by simple randomization to either mobile phone intervention (n=12) or standard care (n=12). The intervention consisted of a SMS and mobile phone voucher component.
The perspectives of the study are that mobile phones may contribute to saving the lives of women and their newborns and achievement of MDGs 4 and 5. Evidence is needed to guide maternal and child health policy makers in developing countries.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wired mothers intervention | Experimental | Device: Wired mothersThe wired mothers' intervention consisted of two components: an automated short messaging service (SMS) system providing wired mothers with unidirectional text messaging and a mobile phone voucher system providing the possibility of direct two-way communication between wired mothers and their primary health care providers. While only women with registered phone numbers received text messages, all women in the intervention group were given mobile phone vouchers to contact their local primary health care provider. |
| Control | No intervention | –The control group received standard care |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women attending antenatal care at one of 24 selected primary healthcare facilities
Key exclusion criteria (1 listed)
- Missing end-of-study questionnaire
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 |
|---|---|---|
| Wired mothersThe wired mothers SMS component provided health education and appointment reminders to encourage attendance at routine antenatal care, skilled delivery attendance and postnatal care. A specially-designed software automatically generated and sent text messages throughout the pregnancy until six weeks after delivery. The frequency and content of the messages varied according to the women's gestational age. Mobile phone vouchers allowed all wired mothers to communicate directly with primary health care providers. Primary health care facilities randomised for intervention and hospitals were provided with a mobile phone with sufficient credit, while wired mothers were given a phone voucher with modest credit and a card with the phone number of her local primary health care provider. | Device | Wired mothers intervention |
Primary outcome
Skilled delivery attendance
Time frame: From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery
We used the WHO definition, whereby skilled delivery attendants are midwifes, doctors or nurses who have been educated and trained in the skills needed to manage pregnancies, childbirth and complications in women and newborns. We also included home deliveries assisted by skilled birth attendants, although international consensus has not been reached on this issue.
2 secondary outcomes
Perinatal mortality
Time frame: From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery
Antenatal care attendance
Time frame: From inclusion of the pregnant women until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Results publication: PubMed 22805598Lund S, Hemed M, Nielsen BB, Said A, Said K, Makungu MH, Rasch V. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial. BJOG. 2012 Sep;119(10):1256-64. doi: 10.1111/j.1471-0528.2012.03413.x. Epub 2012 Jul 17.
- Derived from this study: PubMed 25098184Lund S, Rasch V, Hemed M, Boas IM, Said A, Said K, Makundu MH, Nielsen BB. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial. JMIR Mhealth Uhealth. 2014 Mar 26;2(1):e15. doi: 10.2196/mhealth.2941.
- Derived from this study: PubMed 24438517Lund S, Nielsen BB, Hemed M, Boas IM, Said A, Said K, Makungu MH, Rasch V. Mobile phones improve antenatal care attendance in Zanzibar: a cluster randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 17;14:29. doi: 10.1186/1471-2393-14-29.
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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.
Stine Lund, MD, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wired mothers in people with Pregnancy and Maternal Health, run by University of Copenhagen at 1 site in Tanzania.
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 1 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: finished, as of the sponsor's last update on 29 Mar 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 Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skilled delivery attendance (time frame: From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery). 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 NCT01821222, which also lists 3 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 29 Mar 2013.