Clinical trial NCT01990625: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
Official title: Global Network First Look: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Eclampsia
Placenta Previa
Stillbirth
Fetal Growth Restriction
Keywords: Maternal Near Miss Morbidity
Maternal Mortality
Neonatal Mortality
Gestational Age Dating
Pregnancy Complications
Ultrasound
Stillbirth
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Bill and Melinda Gates Foundation
name: GE Healthcare
First posted: 2013-11-21
Enrollment: 45038
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Composite outcome
timeFrame: Up to 30 months
Secondary outcomes:
measure: Rate of Women with Complicated Deliveries at Health Facilities
timeFrame: Up to 30 months
Other outcomes:
measure: Antenatal Care Utilization
timeFrame: Up to 30 months
Locations:
city: Gemena
country: Congo
facility: Kinshasa School of Public Health
state: Equateur
city: Guatemala City
country: Guatemala
facility: IMSALUD / San Carlos University
city: Eldoret
country: Kenya
facility: Moi University School of Medicine
city: Karachi
country: Pakistan
facility: The Aga Khan University
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
References:
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