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

• ClinicalTrials.gov Identifier: NCT01821222
• Recruitment Status: Completed
• First Posted: March 29, 2013
• Last Update Posted: March 29, 2013
• Sponsor: University of Copenhagen
• Collaborators: Ministry of Health and Social Welfare, Zanzibar; Danish International Development Cooperation
• Information provided by (Responsible Party): Stine Lund, MD, PhD fellow, University of Copenhagen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; Maternal Health; Newborn Death; Health Behavior; mHealth	Device: Wired mothers	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Mobile Phones as a Health Communication Tool to Improve Maternal and Neonatal Health in Zanzibar
• Study Start Date: February 2009
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: April 2010

Arms and Interventions

Arm	Intervention/treatment
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; 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.
No Intervention: Control; The control group received standard care

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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 ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Missing end-of-study questionnaire

Contacts and Locations

Locations

Tanzania

24 Primary Healthcare Facilities on the island on Unguja

Zanzibar, Tanzania

Sponsors and Collaborators

University of Copenhagen

Ministry of Health and Social Welfare, Zanzibar

Danish International Development Cooperation

Investigators

• Principal Investigator: Stine Lund, MD, PhD; University of Copenhagen

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Stine Lund, MD, PhD fellow, MD, PhD fellow, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT01821222
• Other Study ID Numbers: 09-086KU
• First Posted: March 29, 2013
• Last Update Posted: March 29, 2013
• Last Verified: March 2013

Keywords provided by Stine Lund, MD, PhD fellow, University of Copenhagen:

Maternal health; Neonatal health; mHealth; Mobile phones; Access to health services; Health behavior