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Completed

NCT Number: NCT01821222

Wired Mothers - Use of Mobile Phones 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.

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.

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Key information

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

24 Primary Healthcare Facilities on the island on Unguja

Zanzibar, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Missing end-of-study questionnaire

Treatment and study plan

Wired mothers

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perinatal mortality

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

    Calculated as a composite of stillbirths and early neonatal deaths

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danish International Development Cooperation
  • Ministry of Health and Social Welfare, Zanzibar

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 29, 2013
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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