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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT01990625
• Date of registration: 15/11/2013
• Prospective Registration: Yes
• Primary sponsor: NICHD Global Network for Women's and Children's Health
• Public title: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
• Scientific title: Global Network First Look: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
• Date of first enrolment: April 2014
• Target sample size: 45038
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01990625
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Congo, Guatemala, Kenya, Pakistan, Zambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pregnant women who provide consent

- Resident of study cluster

- Enrolled/eligible for the Global Network Maternal and Neonatal Health Registry

- Women >16 weeks gestation at enrollment

Exclusion Criteria:

- Women who are in labor at time of consent



Age minimum: 12 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Placenta Previa

Pregnancy

Fetal Growth Restriction

Stillbirth

Eclampsia

Intervention(s)

Device: Antenatal Ultrasound Scan

Primary Outcome(s)

Composite outcome [Time Frame: Up to 30 months]

Secondary Outcome(s)

Rate of Women with Complicated Deliveries at Health Facilities [Time Frame: Up to 30 months]

Secondary ID(s)

GN First Look Ultrasound

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GE Healthcare

Bill and Melinda Gates Foundation