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Main
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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. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20171128004 |
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Date of registration:
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28/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Handheld Ultrasound to Avert Maternal and Neonatal Deaths in the Philippines
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Scientific title:
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Handheld Ultrasound to Avert Maternal and Neonatal Deaths in 2 Regions of the Philippines: an iBuntis® Intervention Study |
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Date of first enrolment:
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23/07/2014 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20171128004 |
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Study type:
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Interventional |
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Study design:
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Non-randomized
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Phase:
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N/A
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Contacts
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Name:
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Emmanuel Saporno
Baja |
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Address:
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UPM-NIH Institute of Clinical Epidemiology Pedro Gil Ermita
1000
Manila
Philippines |
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Telephone:
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6325254098 |
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Email:
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esbaja@gmail.com |
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Affiliation:
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UPM-National Institutes of Health |
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Name:
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Godofreda
Dalmacion |
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Address:
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Department of Pharmacology and Toxicology UP College of Medicine
1000
Ermita, Manila
Philippines |
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Telephone:
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6325254098 |
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Email:
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jody.dalmacion@gmail.com |
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Affiliation:
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University of the Philippines Manila |
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Key inclusion & exclusion criteria
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Inclusion criteria: Pregnant women in their 20th-26th weeks age of gestation
No associated medical complications
Not in labor and no history of vaginal bleeding
Exclusion criteria: allergy to gel
not capable of giving an informed consent
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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high maternal mortality and neonatal deaths in the Philippines and the incomplete prenatal care
mobile ultrasound, community health workers, prenatal care, maternal complications and neonatal complications
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mobile ultrasound, community health workers, prenatal care, maternal complications and neonatal complications
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Intervention(s)
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Experimental Device
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GE Handheld Ultrsound
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GE Vscan which is a pocket size ultrasound measuring 3.4 inches x 6.5 inches with 4GB micro SD memory Card
Reference was a GE Logic 5
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Primary Outcome(s)
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pregnancy outcomes at labor and delivery maternal and neonatal morbidity and mortality
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Secondary Outcome(s)
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reliability of health workers who were trained on the use of handheld ultrasound during an actual ultrasound session in the communities agreement of ultrasound readings between health workers and Accredited Ultrasonographer,prevalence of abnormal maternal findings on ultrasound on which was between 20th-24th weeks age of gestation prevalence
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Source(s) of Monetary Support
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Canadian government
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
ethics.secretariat@gmail.com
National Ethics Committee
6328372071 Ext. 2112
ethics.secretariat@gmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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25/09/2015 |
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URL:
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