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Intervention Trial to Measure the Effect of Individual Prenatal Information Combined With Mobile Phones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02084680
Recruitment Status : Unknown
Verified March 2014 by Makerere University.
Recruitment status was:  Recruiting
First Posted : March 12, 2014
Last Update Posted : March 17, 2014
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Makerere University

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.

Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: community health workers Not Applicable

  Show Detailed Description

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Study Type : Interventional
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : June 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015

Arm Intervention/treatment
No Intervention: Control
Control group standard care
Experimental: Community Health Workers
individual prenatal education
Behavioral: community health workers
community health workers offering individual prenatal education to pregnant women

Primary Outcome Measures :
  1. delayed bathing of baby [ Time Frame: 24 months ]
    We will measure the primary outcome of interest based on the number of days women delay to bathe their babies after delivery

Secondary Outcome Measures :
  1. institutionalized delivery [ Time Frame: 24 months ]
    Measure proportion of women who deliver their baby in a health centre

Other Outcome Measures:
  1. birth preparedness [ Time Frame: 24 months ]
    We will create a composite variable that will assess the level of birth preparedness based on primary variables mentioned in the protocol

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • pregnant women with gestation of 28 weeks or less, making their first antenatal consultation

Exclusion Criteria:

  • no exclusion criteria has been developed. All women that qualify are eligible for recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02084680

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Contact: Richard Mangwi Ayiasi, Masters +256772829377

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Masindi Recruiting
Masindi, Western Uganda, Uganda, Box 1
Contact: Richard Mangwi Ayiasi, Masters    +256 772829377   
Principal Investigator: Richard Mangwi Ayiasi, Masters         
Sponsors and Collaborators
Makerere University
Institute of Tropical Medicine, Belgium
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Principal Investigator: Richard Mangwi Ayiasi, Masters Makerere University