Handheld Ultrasound to Avert Maternal and Neonatal Deaths in the Philippines (IBuntis)
Study ID: TCTR20171128004
Current status: Completed
Last Updated: November 27, 2017
Tracking Information
Date of Registration in Primary Registry: November 26, 2017
Date of First Enrollment: July 23, 2014 (Actual)
Target Sample Size: 460
Last Updated Date: November 27, 2017
Primary Outcome(s):
  • Outcome name: pregnancy outcomes
       Metric/method of measurement: maternal and neonatal morbidity and mortality
       Time point: at labor and delivery
       Safety Issue?: No

  • Key Secondary Outcomes:
  • Outcome name: reliability of health workers who were trained on the use of handheld ultrasound
       Metric/method of measurement: agreement of ultrasound readings between health workers and Accredited Ultrasonographer
       Time point: during an actual ultrasound session in the communities
       Safety Issue?: No

  • Outcome name: prevalence of abnormal maternal findings on ultrasound
       Metric/method of measurement: prevalence
       Time point: on which was between 20th-24th weeks age of gestation
       Safety Issue?: No

  • Descriptive Information
    Public Title: Handheld Ultrasound to Avert Maternal and Neonatal Deaths in the Philippines
    Scientific Title: Handheld Ultrasound to Avert Maternal and Neonatal Deaths in 2 Regions of the Philippines: an iBuntisยฎ Intervention Study (IBuntis)
    Brief Summary: Background: The major causes of maternal mortality in the Philippines have been hemorrhages and obstructed labor due to placental implantation abnormalities (PIAs), twin pregnancies and fetal malpresentations, which are easily detected by ultrasound. However, women in rural areas and low-income group do not have access to ultrasound during prenatal consultations. We aimed to provide additional evidence particularly on the benefits of handheld ultrasound (HU) for screening pregnancy related abnormalities to avert maternal and neonatal deaths.

    Conclusion: CHW could be trained in the use of HU for scanning 5 obstetrical parameters. Early detection of mothers with abnormalities in these 5 obstetrical parameters could be referred to better-equipped health facilities. Ultrasound can be an excellent point of care screening tool for pregnant women at risk of possible complications and even death during labor and delivery.
    Detailed Description: Methodology: Using a HU, we trained community healthcare workers (CHW) to identify 5 obstetrical conditions: fetal viability and number, placental localization, amniotic fluid volume (AFV) and fetal presentation. Women, between 20th to 24th weeks age of gestation from 2 regons of the Philippines, were scanned using the HU and a reference standard ultrasound machine. Maternal and neonatal deaths averted were estimated as health outcome measures of the study.
    Results: Four hundred sixty women were scanned of which 146 (31.7%) showed abnormal ultrasound results including 17 PIAs, 123 fetal malpresentation, and 3 each for twins and AFV abnormalities. The use of HU averted 29 (6.3%) maternal deaths and 14.6% neonatal deaths after 40% of the breech turned cephalic at the time of delivery. About 7 out of 100 delivered at home with 93% delivering in hospitals/birthing facilities/lying-in centers. Ninety five percent agreement between the ultrasound readings of the trainees and the OB-sonographer trainors and 99% between the readings of HU and reference standard were observed.
    Study Design: Allocation: Non-randomized
    Control: N/A
    Study Endpoint Classification: Efficacy Study
    Intervention Model: Single Group
    Number of Arms: 1
    Masking: N/A (Masked Roles: )
    Primary Purpose: Health Services Research
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: high maternal mortality and neonatal deaths in the Philippines and the incomplete prenatal care
    Study Arms:
  • Arm: 1
  • Intervention Name: GE Handheld Ultrsound
    Type: Experimental
    Classification: Device
    Descriptions: 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
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 460
    Study Start Date (First enrollment): July 23, 2014
    Primary Completion Date: September 25, 2015
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Female
    Age Limit: Minimum 18 Years : Maximum 45 Years
    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

    Accept Healthy Volunteers: Yes
    Countries of Recruitment Philippines, Philippines
    Contact for Public Queries:
    Contact for Public Query's Name: Godofreda Dalmacion
    Phone: 6325254098
    Email: jody.dalmacion@gmail.com
    Postal Address: Department of Pharmacology and Toxicology UP College of Medicine
    State/Province: Ermita, Manila        Postal Code: 1000
    Country: Philippines
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20171128004
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Canadian government
    Study Primary Sponsor: Grand Challenges Canada- Stars in Global HealthProgram
    Study Secondary Sponsor: 1.) None
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Emmanuel Saporno Baja
    Degree: ScD
    Phone: 6325254098
    Email: esbaja@gmail.com
    Postal Address: UPM-NIH Institute of Clinical Epidemiology Pedro Gil Ermita
    State/Province: Manila        Postal Code: 1000
    Country: Philippines
    Contact for Scientific Query's Name: Godofreda Dalmacion
    Degree: MD,MSc,MHPEd
    Phone: +6325254098
    Email: jody.dalmacion@gmail.com
    Postal Address: Department of Pharmacology and Toxicology, UP College of Medicine 547 Pedro Gil, Ermita
    State/Province: Manila        Postal Code: 1000
    Country: Philippines
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