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Clinical Trials/NCT01821222
NCT01821222CompletedNot Applicable

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

University of Copenhagen1 site in 1 country2,550 target enrollmentStarted: February 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,550
Locations
1
Primary Endpoint
Skilled delivery attendance

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
14 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Missing end-of-study questionnaire

Arms & Interventions

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.

Intervention: Wired mothers (Device)

Control

No Intervention

The control group received standard care

Outcomes

Primary Outcomes

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

  • Perinatal mortality(From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery)
  • Antenatal care attendance(From inclusion of the pregnant women until delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stine Lund, MD, PhD fellow

MD, PhD fellow

University of Copenhagen

Study Sites (1)

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