BackgroundIn 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/DesignThis 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.DiscussionIn 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 registrationClinicaltrials.gov (NCT # 01990625)

Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.

Limited, screening obstetric US performed by midwives with focused, obstetric US training demonstrates the diagnostic impact for identifying conditions associated with high-risk pregnancies in 6.7 to 12% of patients screened. The limited obstetric US improved diagnosis of early pregnancy complication as well as later gestation twins and malpresentation. Midwives who have undergone focused 6-week limited obstetric US training proved capable of diagnosing twins and fetal presentation with high sensitivity and specificity.

Prior studies have suggested that obstetrical (OB) ultrasound in low- and middle-income countries has aided in detection of high-risk conditions, which in turn could improve OB management. We are participating in a cluster-randomized clinical trial of OB ultrasound, which is designed to assess the effect of basic OB ultrasound on maternal mortality, fetal mortality, neonatal mortality, and maternal near-miss in 5 low-income countries. We designed a 2-week course in basic OB ultrasound, followed by 12 weeks of oversight, to train health care professionals with no prior ultrasound experience to perform basic OB ultrasound to screen for high-risk pregnancies. All patients with high-risk pregnancies identified by the trainees were referred to higher-level health facilities where fully trained sonographers confirmed the diagnoses before any actions were taken. Although there have been several published studies on basic OB ultrasound training courses for health care workers in low- and middle-income countries, quality control reporting has been limited. The purpose of this study is to report on quality control results of these trainees. Health care workers trained in similar courses could have an adjunctive role in ultrasound screening for high-risk OB conditions where access to care is limited. After completion of the ultrasound course, 41 trainees in 5 countries performed 3801 ultrasound examinations during a 12-week pilot period. Each examination was reviewed by ultrasound trainers for errors in scanning parameters and errors in diagnosis, using predetermined criteria. Of the 32,480 images comprising the 3801 examinations, 94.8% were rated as satisfactory by the reviewers. There was 99.4% concordance between trainee and reviewer ultrasound diagnosis. The results suggest that trained health care workers could play a role in ultrasound screening for high-risk OB conditions.