A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
Condition: Pregnancy; Eclampsia; Placenta Previa; Stillbirth; Fetal Growth Restriction
MeSH terms: Eclampsia; Placenta Previa; Fetal Growth Retardation; Stillbirth
Study type: Interventional

Summary: 
      In many low-income countries, the use of ultrasound by medical officers and non-physician
      health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a
      new intervention requiring authoritative investigation. The primary hypothesis to be assessed
      in this study is that antenatal ultrasound screenings performed by medical officers and
      non-physician health care staff will significantly reduce a composite outcome consisting of
      maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource
      settings. Underpinning this hypothesis are two assumptions. The first assumption is that
      antenatal detection of complicated pregnancies will lead to appropriate referral at the right
      time for complicated pregnancies to comprehensive emergency obstetric and neonatal care
      (EmONC) facilities. The second assumption is that ultrasound's introduction will increase
      antenatal attendance leading to greater rates of institutional delivery. To assess these
      underlying assumptions beyond the composite end point, this study will investigate the health
      system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates,
      institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC
      facilities, cesarean section rates (both planned and emergent) and an assessment of medical
      officers and non-physician health care provider ultrasound competence and training quality.
    

Detailed description: 
      The use of ultrasound by physician and non-physician health care staff for antenatal
      identification of complicated pregnancies is a potentially effective intervention; however,
      authoritative investigation in many low-resource settings is needed to establish its
      potential impact. The investigators propose to undertake a multi-country, cluster randomized
      trial to assess the impact of antenatal ultrasound screening performed by community physician
      and non-physician health care staff on a composite outcome consisting of maternal mortality
      and near miss maternal mortality, stillbirth and neonatal mortality in low-resource settings.
      Underpinning this objective are several assumptions. The first assumption is that
      ultrasound's introduction will increase antenatal attendance and improved outcomes due to the
      antenatal care alone, and greater rates of institutional delivery. The second assumption is
      that ultrasound use will lead to antenatal detection of complicated pregnancies and timely
      and appropriate referral for complicated pregnancies to comprehensive emergency obstetric and
      neonatal care (EmONC) facilities. Increases in antenatal care utilization and referral will
      result in a decrease in a composite outcome including maternal mortality and near miss
      mortality, stillbirth and neonatal death. Secondary outcomes to be evaluated include
      antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral
      rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent),
      an assessment of community physician and non-physician health care provider ultrasound
      training and competence and the cost-effectiveness of ultrasound in community health
      facilities. The investigators will also determine causes for non-compliance with
      recommendations for referral.

      In summary, this trial will evaluate whether training antenatal health care providers to
      perform basic obstetric ultrasonography, and using these trainees to provide routine
      ultrasounds in primary care clinics and to refer appropriately will improve pregnancy
      outcomes in low-resource settings.

      To assess the impact of ultrasound, the investigators propose to utilize an existing research
      infrastructure, the Global Network for Women's and Children's Health Research (Global
      Network), which currently includes 7 sites in 6 countries, India (2), Pakistan, Kenya,
      Zambia, DRC and Guatemala. The investigators of the Global Network have an ongoing maternal
      and newborn health registry to document all pregnancies and their outcomes to 6 weeks
      post-delivery in more than 100 communities. Thus, population-based rates of maternal
      mortality and morbidity, stillbirth, and neonatal mortality and morbidity, as well as health
      care utilization, are being obtained. A sub-set of these clusters will be utilized for the
      ultrasound trial.

      RTI International serves as the data coordinating center for the Global Network to help
      facilitate the design and conduct of the trial, manage the trial related data, and provide
      statistical analyses of the trial results. GE Healthcare will provide the ultrasound
      equipment, and will also fund the University of Washington to provide training and technical
      support on the implementation of ultrasound in community settings. Together, the Global
      Network with the support of the University of Washington and GE Healthcare will maximize the
      resources necessary to conduct a definitive trial on the potential impact of ultrasound to
      reduce maternal and newborn mortality and maternal morbidity in low-resource settings.
    

Intervention name(s): Antenatal Ultrasound Scan
Intervention type(s): Device
Intervention description(s): Women in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Maternal Near Miss Morbidity; Maternal Mortality; Neonatal Mortality; Gestational Age Dating; Pregnancy Complications; Ultrasound; Stillbirth