CClinicalTrials.gg
CompletedNCT01821222Updated Mar 29, 2013

Wired Mothers - Use of Mobile Phones to Improve Maternal and Neonatal Health in Zanzibar

An interventional study of Wired mothers in Pregnancy, Maternal Health and Newborn Death, sponsored by University of Copenhagen. Completed at 1 site in Tanzania. Open to female participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-03-29.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,550
Allocation
Randomized
Ages
14 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Pregnancy
  • Maternal Health
  • Newborn Death
  • Health Behavior
  • mHealth

Keywords

  • Maternal health
  • Neonatal health
  • mHealth
  • Mobile phones
  • Access to health services
  • Health behavior
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Pregnant women attending antenatal care at one of 24 selected primary healthcare facilities

Exclusion criteria

Exclusion Criteria:

  • Missing end-of-study questionnaire
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,550 participants (actual)

Study arms

  • Experimental
    Wired mothers intervention

    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.

    Device: Wired mothers

  • No intervention
    Control

    The control group received standard care

Interventions

  • DeviceWired mothers

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery

Secondary outcomes

  1. Perinatal mortality

    Calculated as a composite of stillbirths and early neonatal deaths

    Time frame: From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery

  2. Antenatal care attendance

    Time frame: From inclusion of the pregnant women until delivery

Other outcomes

  1. Anti tetanus vaccination

    Time frame: From inclusion of the pregnant women until delivery

  2. Preventive malaria treatment

    Time frame: From inclusion of the pregnant women until delivery

  3. Antepartum and intrapartum referrals

    Time frame: From inclusion of the pregnant women until postpartum period

  4. Number of calls between women and midwifes

    Time frame: From inclusion of the pregnant women until 42 days after delivery

07

Study locations

1 site
  • 24 Primary Healthcare Facilities on the island on Unguja
    Zanzibar, Tanzania
08

References and documents

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 22805598 ↗
  • Lund 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 25098184 ↗
  • Lund 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01821222
Lead sponsor
University of Copenhagen
Collaborators
Ministry of Health and Social Welfare, Zanzibar, Danish International Development Cooperation
Responsible party
Stine Lund, MD, PhD fellow (MD, PhD fellow, University of Copenhagen) — Principal investigator
First posted
Mar 29, 2013
Start date
Feb 2009
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Mar 29, 2013

Study contacts

Stine Lund, MD, PhD
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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