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

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ClinicalTrials.gov Identifier: NCT01990625
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : September 29, 2016
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
GE Healthcare
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

November 15, 2013
November 21, 2013
September 29, 2016
April 2014
August 2016   (Final data collection date for primary outcome measure)
Composite outcome [ Time Frame: Up to 30 months ]
Introduction of ultrasound will decrease the composite outcome of maternal mortality and near miss maternal mortality events and stillbirths plus early neonatal mortality.
Same as current
Complete list of historical versions of study NCT01990625 on ClinicalTrials.gov Archive Site
Rate of Women with Complicated Deliveries at Health Facilities [ Time Frame: Up to 30 months ]
Introduction of ultrasound will significantly increase the percentage of women with complicated pregnancies such as twins, breeches, etc. who deliver in a hospital.
Same as current
Antenatal Care Utilization [ Time Frame: Up to 30 months ]
This outcome will be a process measure of antenatal care utilization (including both the proportion of women with any antenatal care and the median number of antenatal care visits.)
Same as current
 
A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
Global Network First Look: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
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.

The use of ultrasound by physician and non-physician health care staff for antenatal identification of complicated pregnancies is a potentially effective intervention; however, authoritative investigation in many low-resource settings is needed to establish its potential impact. The investigators propose to undertake a multi-country, cluster randomized trial to assess the impact of antenatal ultrasound screening performed by community physician and non-physician health care staff on a composite outcome consisting of maternal mortality and near miss maternal mortality, stillbirth and neonatal mortality in low-resource settings. Underpinning this objective are several assumptions. The first assumption is that ultrasound's introduction will increase antenatal attendance and improved outcomes due to the antenatal care alone, and greater rates of institutional delivery. The second assumption is that ultrasound use will lead to antenatal detection of complicated pregnancies and timely and appropriate referral for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. Increases in antenatal care utilization and referral will result in a decrease in a composite outcome including maternal mortality and near miss mortality, stillbirth and neonatal death. Secondary outcomes to be evaluated include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent), an assessment of community physician and non-physician health care provider ultrasound training and competence and the cost-effectiveness of ultrasound in community health facilities. The investigators will also determine causes for non-compliance with recommendations for referral.

In summary, this trial will evaluate whether training antenatal health care providers to perform basic obstetric ultrasonography, and using these trainees to provide routine ultrasounds in primary care clinics and to refer appropriately will improve pregnancy outcomes in low-resource settings.

To assess the impact of ultrasound, the investigators propose to utilize an existing research infrastructure, the Global Network for Women's and Children's Health Research (Global Network), which currently includes 7 sites in 6 countries, India (2), Pakistan, Kenya, Zambia, DRC and Guatemala. The investigators of the Global Network have an ongoing maternal and newborn health registry to document all pregnancies and their outcomes to 6 weeks post-delivery in more than 100 communities. Thus, population-based rates of maternal mortality and morbidity, stillbirth, and neonatal mortality and morbidity, as well as health care utilization, are being obtained. A sub-set of these clusters will be utilized for the ultrasound trial.

RTI International serves as the data coordinating center for the Global Network to help facilitate the design and conduct of the trial, manage the trial related data, and provide statistical analyses of the trial results. GE Healthcare will provide the ultrasound equipment, and will also fund the University of Washington to provide training and technical support on the implementation of ultrasound in community settings. Together, the Global Network with the support of the University of Washington and GE Healthcare will maximize the resources necessary to conduct a definitive trial on the potential impact of ultrasound to reduce maternal and newborn mortality and maternal morbidity in low-resource settings.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Pregnancy
  • Eclampsia
  • Placenta Previa
  • Stillbirth
  • Fetal Growth Restriction
Device: Antenatal Ultrasound Scan
Women in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications.
  • Experimental: Ultrasound scan
    The group is pregnant women who reside in an intervention cluster who receive at least one antenatal ultrasound scan during antenatal care during the study time period.
    Intervention: Device: Antenatal Ultrasound Scan
  • No Intervention: Routine antenatal care
    The group is pregnant women that reside in the control clusters during the study time period. The group received routine antenatal care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45038
16000
September 2016
August 2016   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
12 Years to 55 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Congo,   Guatemala,   Kenya,   Pakistan,   Zambia
 
 
NCT01990625
GN First Look Ultrasound
Yes
Not Provided
Not Provided
NICHD Global Network for Women's and Children's Health
NICHD Global Network for Women's and Children's Health
  • Bill and Melinda Gates Foundation
  • GE Healthcare
Not Provided
NICHD Global Network for Women's and Children's Health
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP