- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821222
Wired Mothers - Use of Mobile Phones to Improve Maternal and Neonatal Health in Zanzibar
Mobile Phones as a Health Communication Tool 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zanzibar, Tanzania
- 24 Primary Healthcare Facilities on the island on Unguja
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women attending antenatal care at one of 24 selected primary healthcare facilities
Exclusion Criteria:
- Missing end-of-study questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From inclusion of the pregnant women until 7 days after delivery. Assessed at delivery and 7 days after delivery
|
Antenatal care attendance
Time Frame: From inclusion of the pregnant women until delivery
|
From inclusion of the pregnant women until delivery
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti tetanus vaccination
Time Frame: From inclusion of the pregnant women until delivery
|
From inclusion of the pregnant women until delivery
|
Preventive malaria treatment
Time Frame: From inclusion of the pregnant women until delivery
|
From inclusion of the pregnant women until delivery
|
Antepartum and intrapartum referrals
Time Frame: From inclusion of the pregnant women until postpartum period
|
From inclusion of the pregnant women until postpartum period
|
Number of calls between women and midwifes
Time Frame: From inclusion of the pregnant women until 42 days after delivery
|
From inclusion of the pregnant women until 42 days after delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stine Lund, MD, PhD, University of Copenhagen
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-086KU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Turku University HospitalUniversity of TurkuCompleted
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Hopital Antoine BeclereUnknown
Clinical Trials on Wired mothers
-
National Taiwan University HospitalInsight Medical SolutionsRecruiting
-
Project Concern InternationalHarvard School of Public Health (HSPH); Purdue University; National Institute... and other collaboratorsCompletedChild Nutrition and Early Child DevelopmentTanzania
-
University of FloridaCompletedPediatric Obesity | RecruitmentUnited States
-
Cambridge University Hospitals NHS Foundation TrustWithdrawn
-
Northwestern UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingPostpartum Depression | Parenting | Child Development | Child Self-RegulationUnited States
-
NMP Medical Research InstituteWarwick Research Services; Mothers Touch Foundation, IndiaCompletedPost Partum Depression | Psychological Distress | MoodIndia
-
Yale UniversityNational Institute on Drug Abuse (NIDA)CompletedMaternal Substance Use | Child Abuse and NeglectUnited States
-
University of Missouri-ColumbiaCompleted
-
Ziauddin UniversityUniversiti Sains MalaysiaNot yet recruitingGingivitis | Dental PlaquePakistan
-
Sidra Medical and Research CenterNorthwestern UniversityUnknownDiabetes | Postpartum Depression | Anxiety