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Open Access Study protocol

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

Elizabeth M McClure1*, Robert O Nathan2, Sarah Saleem3, Fabian Esamai4, Ana Garces5, Elwyn Chomba6, Antoinette Tshefu7, David Swanson2, Hillary Mabeya8, Lester Figuero9, Waseem Mirza10, David Muyodi4, Holly Franklin11, Adrien Lokangaka12, Dieudonne Bidashimwa12, Omrana Pasha3, Musaku Mwenechanya6, Carl L Bose13, Waldemar A Carlo14, K Michael Hambidge15, Edward A Liechty16, Nancy Krebs15, Dennis D Wallace1, Jonathan Swanson2, Marion Koso-Thomas17, Rexford Widmer18 and Robert L Goldenberg19

Author Affiliations

1 Department of Statistics and Epidemiology, RTI International, Durham, NC, USA

2 Department of Radiology, University of Washington, Seattle, WA, USA

3 Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan

4 Department of Pediatrics, Moi University School of Medicine, Eldoret, Kenya

5 Francisco Marroquin University, Guatemala City, Guatemala

6 Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia

7 University of Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo

8 Department of Obstetrics, Moi University School of Medicine, Eldoret, Kenya

9 FANCAP, Guatemala City, Guatemala

10 Department of Radiology, Aga Khan University, Karachi, Pakistan

11 RTI International, Durham, NC, USA

12 Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo

13 Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

14 Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA

15 Department of Pediatrics, University of Colorado Health Care System, Denver, CO, USA

16 Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA

17 Eunice Kennedy Shriver NICHD, Bethesda, MD, USA

18 GE Healthcare, Wisconsin, USA

19 Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA

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BMC Pregnancy and Childbirth 2014, 14:73  doi:10.1186/1471-2393-14-73

Published: 17 February 2014

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)

Keywords:
Maternal mortality; Maternal near miss; Perinatal mortality; Obstetric ultrasound; Low-income countries