A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings

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.

Conditions

• Pregnancy
• Eclampsia
• Placenta Previa
• Stillbirth
• Fetal Growth Restriction

Interventions

DEVICE

Antenatal Ultrasound Scan

Women in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• GE Healthcare

  collaborator INDUSTRY

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2016-08-31

Completion

2016-09-30

Countries

• Guatemala
• Kenya
• Pakistan
• Republic of the Congo
• Zambia

Study Locations