title: First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov (NCT # 01990625).
authors.affiliation: Department of Statistics and Epidemiology, RTI International, Durham, NC, USA. mcclure@rti.org.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: McClure
authors.forename: Robert O
authors.initials: RO
authors.lastname: Nathan
authors.forename: Sarah
authors.initials: S
authors.lastname: Saleem
authors.forename: Fabian
authors.initials: F
authors.lastname: Esamai
authors.forename: Ana
authors.initials: A
authors.lastname: Garces
authors.forename: Elwyn
authors.initials: E
authors.lastname: Chomba
authors.forename: Antoinette
authors.initials: A
authors.lastname: Tshefu
authors.forename: David
authors.initials: D
authors.lastname: Swanson
authors.forename: Hillary
authors.initials: H
authors.lastname: Mabeya
authors.forename: Lester
authors.initials: L
authors.lastname: Figuero
authors.forename: Waseem
authors.initials: W
authors.lastname: Mirza
authors.forename: David
authors.initials: D
authors.lastname: Muyodi
authors.forename: Holly
authors.initials: H
authors.lastname: Franklin
authors.forename: Adrien
authors.initials: A
authors.lastname: Lokangaka
authors.forename: Dieudonne
authors.initials: D
authors.lastname: Bidashimwa
authors.forename: Omrana
authors.initials: O
authors.lastname: Pasha
authors.forename: Musaku
authors.initials: M
authors.lastname: Mwenechanya
authors.forename: Carl L
authors.initials: CL
authors.lastname: Bose
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: K Michael
authors.initials: KM
authors.lastname: Hambidge
authors.forename: Edward A
authors.initials: EA
authors.lastname: Liechty
authors.forename: Nancy
authors.initials: N
authors.lastname: Krebs
authors.forename: Dennis D
authors.initials: DD
authors.lastname: Wallace
authors.forename: Jonathan
authors.initials: J
authors.lastname: Swanson
authors.forename: Marion
authors.initials: M
authors.lastname: Koso-Thomas
authors.forename: Rexford
authors.initials: R
authors.lastname: Widmer
authors.forename: Robert L
authors.initials: RL
authors.lastname: Goldenberg
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D003223:Congo / Q000453:epidemiology; D003906:Developing Countries; D005260:Female; D005865:Gestational Age; D006166:Guatemala / Q000453:epidemiology; D006801:Humans; D007226:Infant Mortality / Q000639:trends; D007231:Infant, Newborn; D007630:Kenya / Q000453:epidemiology; D008427:Maternal Health Services / Q000592:standards*; D008428:Maternal Mortality / Q000639:trends; D008429:Maternal Welfare; D008880:Midwifery / Q000592:standards; D009017:Morbidity / Q000639:trends; D010154:Pakistan / Q000453:epidemiology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000000981:diagnostic imaging* / Q000453:epidemiology; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods*; D012424:Rural Population; D012959:Socioeconomic Factors; D016216:Ultrasonography, Prenatal / Q000592:standards*; D015024:Zambia / Q000453:epidemiology