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

Pregnancy Clinical Trial

Official title:

Mobile Phones as a Health Communication Tool to Improve Maternal and Neonatal Health in Zanzibar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821222
• Other study ID #: 09-086KU
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: March 28, 2013
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zanzibar: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2550
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Missing end-of-study questionnaire

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Device:
• Wired 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.

Locations

Country	Name	City	State
Tanzania	24 Primary Healthcare Facilities on the island on Unguja	Zanzibar

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Danish International Development Cooperation, Ministry of Health and Social Welfare, Zanzibar

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

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.147 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti tetanus vaccination		From inclusion of the pregnant women until delivery	No
Other	Preventive malaria treatment		From inclusion of the pregnant women until delivery	No
Other	Antepartum and intrapartum referrals		From inclusion of the pregnant women until postpartum period	No
Other	Number of calls between women and midwifes		From inclusion of the pregnant women until 42 days after delivery	No
Primary	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.	From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery	No
Secondary	Perinatal mortality	Calculated as a composite of stillbirths and early neonatal deaths	From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery	No
Secondary	Antenatal care attendance		From inclusion of the pregnant women until delivery	No

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