NCT01821222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,550

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

March 26, 2013

Last Update Submit

March 28, 2013

Conditions

Keywords

Maternal healthNeonatal healthmHealthMobile phonesAccess to health servicesHealth behavior

Outcome Measures

Primary Outcomes (1)

  • Skilled delivery attendance

    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 Outcomes (2)

  • 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

Other Outcomes (4)

  • Anti tetanus vaccination

    From inclusion of the pregnant women until delivery

  • Preventive malaria treatment

    From inclusion of the pregnant women until delivery

  • Antepartum and intrapartum referrals

    From inclusion of the pregnant women until postpartum period

  • +1 more other outcomes

Study Arms (2)

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.

Device: Wired mothers

Control

NO INTERVENTION

The control group received standard care

Interventions

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.

Wired mothers intervention

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Missing end-of-study questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

24 Primary Healthcare Facilities on the island on Unguja

Zanzibar, Tanzania

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Perinatal DeathHealth Behavior

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Stine Lund, MD, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD fellow

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 29, 2013

Study Start

February 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations