Intervention Trial to Measure the Effect of Individual Prenatal Information Combined With Mobile Phones
A Community Trial to Measure the Effect of Individual Prenatal Education With Mobile Phone Consultations Offered to Pregnant Women in Masindi and Kiryandongo, Western Uganda
1 other identifier
interventional
1
1 country
1
Brief Summary
Introduction There is compelling evidence for scheduled home visits to improve newborn health. There is also a growing wealth of evidence to support the use of mobile phones as a public health tool in low and middle-income countries. UNICEF and WHO have recommended implementation of home visits for newborn care improvement. In sub Saharan Africa the evidence for a combined scheduled home visit and mobile phone technology to improve neonatal health is lacking. In this study the investigators aim to determine the effect of scheduled home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs) combined with mobile phone consultations on newborn care in Masindi, Uganda. Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in Uganda from May 2013 to June 2014. A mixed method data collection technique will be used. Our overarching hypothesis is that survival of the newborn requires a continuum of care from pregnancy to the newborn period. Eight health centres each will be randomly allocated to the intervention arm and a control arm. Five villages will be randomly selected from each of the catchment areas of the intervention health centres and one VHT purposively selected from each of the villages. Intervention arm will receive VHTs equipped with mobile phones making four scheduled home visits to women while the control arm will receive the standard care for prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended newborn care practices. VHTs can also make instant telephone consultations with the midwife for a second opinion. A closed caller group for the mobile telephone consultation is already negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow lower tariff rates. Our primary outcome variables of interest are hygienic cord care (specifically application of substances on the cord), thermal care (specifically delayed bathing of the baby soon after birth), initiation of breastfeeding within one hour and avoiding pre-lacteal feeds. Secondary outcomes like completed four antenatal visits, institutionalized delivery were also assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Jun 2013
Typical duration for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 17, 2014
March 1, 2014
1.3 years
March 10, 2014
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
delayed bathing of baby
We will measure the primary outcome of interest based on the number of days women delay to bathe their babies after delivery
24 months
Secondary Outcomes (1)
institutionalized delivery
24 months
Other Outcomes (1)
birth preparedness
24 months
Study Arms (2)
Control
NO INTERVENTIONControl group standard care
Community Health Workers
EXPERIMENTALindividual prenatal education
Interventions
community health workers offering individual prenatal education to pregnant women
Eligibility Criteria
You may qualify if:
- pregnant women with gestation of 28 weeks or less, making their first antenatal consultation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Makerere Universitylead
- Institute of Tropical Medicine, Belgiumcollaborator
Study Sites (1)
Masindi
Masindi, Western Uganda, Box 1, Uganda
Related Publications (2)
Mangwi Ayiasi R, Kolsteren P, Batwala V, Criel B, Orach CG. Effect of Village Health Team Home Visits and Mobile Phone Consultations on Maternal and Newborn Care Practices in Masindi and Kiryandongo, Uganda: A Community-Intervention Trial. PLoS One. 2016 Apr 21;11(4):e0153051. doi: 10.1371/journal.pone.0153051. eCollection 2016.
PMID: 27101379DERIVEDMangwi Ayiasi R, Atuyambe LM, Kiguli J, Garimoi Orach C, Kolsteren P, Criel B. Use of mobile phone consultations during home visits by Community Health Workers for maternal and newborn care: community experiences from Masindi and Kiryandongo districts, Uganda. BMC Public Health. 2015 Jun 18;15:560. doi: 10.1186/s12889-015-1939-3.
PMID: 26084369DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Mangwi Ayiasi, Masters
Makerere University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2014
First Posted
March 12, 2014
Study Start
June 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2015
Last Updated
March 17, 2014
Record last verified: 2014-03