Abstract
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)
Highlights
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
In summary, our trial will evaluate whether introduction of ultrasound during antenatal care improves pregnancy outcomes in rural, low-resource settings
Sample size estimates for potential decreases in the composite maternal, fetal, and neonatal outcomes with 90% power and alpha at 0.05 for rates of the composite outcome in the range of 70 to 90 events per 1000 deliveries, target reductions of 20% to 25%, an intra-cluster correlation (ICC) of 0.005
Summary
The cluster RCT will evaluate the impact of a communitybased intervention focused on introduction of obstetric ultrasound into ANC by community health providers. The successful introduction of ultrasound into primary health centers and clinics will require an evaluation of the health systems’ capabilities, and discussion with local policy makers and providers to ensure that the referral hospitals can appropriately manage the obstetric complications referred to it. With the decreasing costs and increasing availability of ultrasound in low-resource settings, understanding the potential impact of ultrasound on the health of the mother and her fetus but on the health system is needed. This multi-faceted intervention, which represents a unique partnership of academic and clinical investigators supported through public and private funding, will provide results to inform the issues around ultrasound use.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
