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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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9 November 2020 |
Main ID: |
ISRCTN18270380 |
Date of registration:
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14/10/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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PANDA mHealth system for antenatal care
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Scientific title:
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Usability and feasibility of a mobile health system to provide comprehensive antenatal care in low-income countries: PANDA mHealth pilot study in Madagascar
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Date of first enrolment:
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13/01/2015 |
Target sample size:
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300 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN18270380 |
Study type:
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Observational |
Study design:
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Cross-sectional pilot feasibility study (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Madagascar
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Anne Caroline
Benski |
Address:
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Boulevard Saint Georges 66
1205
Geneva
Switzerland |
Telephone:
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+41 787 397 261 |
Email:
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Anne-Caroline.Benski@hcuge.ch |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Pregnant women
Exclusion criteria: Patients who are not able to comply with the protocol
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Most maternal and newborn deaths are related to direct complications during pregnancy and childbirth and could be reduced by providing comprehensive antenatal care Pregnancy and Childbirth
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Intervention(s)
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The women enrolled will attend a number of ANC visits along the pregancy according with WHO recomandations and the stage of pregnancy at the time of the enrollment. A random ID number will be assigned to each women, to which their clinical data and test results will be linked. ANC visits will start with the collection of social/personal data and medical history and then screening tests (HIV, HPV syphilis, malaria, haemoglobin, glucose) as well as other measurements (temperature, weight, height, blood pressure, uterine height) will be conducted. All results will be available at the end of the visits except for the HPV where the self-sampling of the women will be collected and sent to the virology laboratory in Geneva and destroyed after one year. Abnormal results will be signalised immediately by the smartphone and the woman will be referred to the hospital. Once the screening is completed, the PANDA team will proceed to health education, focusing on maternal and newborn care and birth preparedness as well as family planning. On a daily basis, data and test results will be sent via the mobile phone to the medical unit, for data verification and personalised intervention plans in order to optimise the management of pregnancies and childbirths, and to ensure appropriate care for high risk pregnancies.
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Primary Outcome(s)
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PANDA system feasibility using the Redmine tool an open source flexible project management web application with a ticket tracking system collecting all the items in real time during the ANC visits.
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Secondary Outcome(s)
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1. The capacity of PANDA system to provide standardised and high quality ANC, measured using the percentage of missing data and deviations from the WHO guidelines of the ANC visits. Data verification done at the end of each day of antenatal visits 2. The capacity of the system to map the pregnancies in order to help health personnel for a better management of the resources, measured using the number of women referred to the hospital for treatment and follow-up. Data is verified daily by the hospital obstetric team
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Source(s) of Monetary Support
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Commission of Humanitarian Affairs, Geneva, Romand Group of the Swiss Society of Gynecology, Valdese Church
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/10/2015 |
URL:
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