Clinical trial NCT01821222: Wired Mothers - Use of Mobile Phones to Improve Maternal and Neonatal Health in Zanzibar
Official title: Mobile Phones as a Health Communication Tool to Improve Maternal and Neonatal Health in Zanzibar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Maternal Health
Newborn Death
Health Behavior
mHealth
Keywords: Maternal health
Neonatal health
mHealth
Mobile phones
Access to health services
Health behavior
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Welfare, Zanzibar
name: Danish International Development Cooperation
First posted: 2013-03-29
Enrollment: 2550
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Missing end-of-study questionnaire

Primary outcomes:
measure: Skilled delivery attendance
timeFrame: From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery
Secondary outcomes:
measure: Perinatal mortality
timeFrame: From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery
measure: Antenatal care attendance
timeFrame: From inclusion of the pregnant women until delivery
Other outcomes:
measure: Anti tetanus vaccination
timeFrame: From inclusion of the pregnant women until delivery
measure: Preventive malaria treatment
timeFrame: From inclusion of the pregnant women until delivery
measure: Antepartum and intrapartum referrals
timeFrame: From inclusion of the pregnant women until postpartum period
measure: Number of calls between women and midwifes
timeFrame: From inclusion of the pregnant women until 42 days after delivery
Locations:
city: Zanzibar
country: Tanzania
facility: 24 Primary Healthcare Facilities on the island on Unguja
Study officials:
affiliation: University of Copenhagen
name: Stine Lund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.