First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings

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  • McClure, Elizabeth M
    • Other Affiliation: Department of Statistics and Epidemiology, RTI International, Durham, NC, USA
  • Nathan, Robert O
    • Other Affiliation: Department of Radiology, University of Washington, Seattle, WA, USA
  • Saleem, Sarah
    • Other Affiliation: Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan
  • Esamai, Fabian
    • Other Affiliation: Department of Pediatrics, Moi University School of Medicine, Eldoret, Kenya
  • Garces, Ana
    • Other Affiliation: Francisco Marroquin University, Guatemala City, Guatemala
  • Chomba, Elwyn
    • Other Affiliation: Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia
  • Tshefu, Antoinette
    • Other Affiliation: University of Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
  • Swanson, David
    • Other Affiliation: Department of Radiology, University of Washington, Seattle, WA, USA
  • Mabeya, Hillary
    • Other Affiliation: Department of Obstetrics, Moi University School of Medicine, Eldoret, Kenya
  • Figuero, Lester
    • Other Affiliation: FANCAP, Guatemala City, Guatemala
  • Mirza, Waseem
    • Other Affiliation: Department of Radiology, Aga Khan University, Karachi, Pakistan
  • Muyodi, David
    • Other Affiliation: Department of Pediatrics, Moi University School of Medicine, Eldoret, Kenya
  • Franklin, Holly
    • Other Affiliation: RTI International, Durham, NC, USA
  • Lokangaka, Adrien
    • Other Affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
  • Bidashimwa, Dieudonne
    • Other Affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
  • Pasha, Omrana
    • Other Affiliation: Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan
  • Mwenechanya, Musaku
    • Other Affiliation: Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia
  • Bose, Carl
    • Affiliation: School of Medicine, Department of Pediatrics
  • Carlo, Waldemar A
    • Other Affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA
  • Hambidge, K
    • Other Affiliation: Department of Pediatrics, University of Colorado Health Care System, Denver, CO, USA
  • Liechty, Edward A
    • Other Affiliation: Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA
  • Krebs, Nancy
    • Other Affiliation: Department of Pediatrics, University of Colorado Health Care System, Denver, CO, USA
  • Wallace, Dennis D
    • Other Affiliation: Department of Statistics and Epidemiology, RTI International, Durham, NC, USA
  • Swanson, Jonathan
    • Other Affiliation: Department of Radiology, University of Washington, Seattle, WA, USA
  • Koso-Thomas, Marion
    • Other Affiliation: Eunice Kennedy Shriver NICHD, Bethesda, MD, USA
  • Widmer, Rexford
    • Other Affiliation: GE Healthcare, Wisconsin, USA
  • Goldenberg, Robert L
    • Other Affiliation: Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA
Abstract
  • Abstract Background In high-resource settings, obstetric ultrasound is a standard component of prenatal care used to identify pregnancy complications and to establish an accurate gestational age in order to improve obstetric care. Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown. Methods/Design This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by health care staff on a composite outcome consisting of maternal mortality and maternal near-miss, stillbirth and neonatal mortality in low-resource community settings. The trial will utilize an existing research infrastructure, the Global Network for Women’s and Children’s Health Research with sites in Pakistan, Kenya, Zambia, Democratic Republic of Congo and Guatemala. A maternal and newborn health registry in defined geographic areas which documents all pregnancies and their outcomes to 6 weeks post-delivery will provide population-based rates of maternal mortality and morbidity, stillbirth, neonatal mortality and morbidity, and health care utilization for study clusters. A total of 58 study clusters each with a health center and about 500 births per year will be randomized (29 intervention and 29 control). The intervention includes training of health workers (e.g., nurses, midwives, clinical officers) to perform ultrasound examinations during antenatal care, generally at 18–22 and at 32–36 weeks for each subject. Women who are identified as having a complication of pregnancy will be referred to a hospital for appropriate care. Finally, the intervention includes community sensitization activities to inform women and their families of the availability of ultrasound at the antenatal care clinic and training in emergency obstetric and neonatal care at referral facilities. Discussion In summary, our trial will evaluate whether introduction of ultrasound during antenatal care improves pregnancy outcomes in rural, low-resource settings. The intervention includes training for ultrasound-naïve providers in basic obstetric ultrasonography and then enabling these trainees to use ultrasound to screen for pregnancy complications in primary antenatal care clinics and to refer appropriately. Trial registration Clinicaltrials.gov ( NCT#01990625 )
Date of publication
DOI
Identifier
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Elizabeth M McClure et al.; licensee BioMed Central Ltd.
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Journal title
  • BMC Pregnancy and Childbirth
Journal volume
  • 14
Journal issue
  • 1
Page start
  • 73
Language
  • English
Is the article or chapter peer-reviewed?
  • Yes
ISSN
  • 1471-2393
Bibliographic citation
  • BMC Pregnancy and Childbirth. 2014 Feb 17;14(1):73
Publisher
  • BioMed Central Ltd
Access right
  • Open Access
Date uploaded
  • September 22, 2015

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