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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by NICHD Global Network for Women's and Children's Health
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
GE Healthcare
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT01990625
First received: November 15, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pregnancy
Eclampsia
Placenta Previa
Stillbirth
Fetal Growth Restriction
Device: Antenatal Ultrasound Scan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Global Network First Look: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Composite outcome [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
    Introduction of ultrasound will decrease the composite outcome of maternal mortality and near miss maternal mortality events and stillbirths plus early neonatal mortality.


Secondary Outcome Measures:
  • Rate of Women with Complicated Deliveries at Health Facilities [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
    Introduction of ultrasound will significantly increase the percentage of women with complicated pregnancies such as twins, breeches, etc. who deliver in a hospital.


Other Outcome Measures:
  • Antenatal Care Utilization [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
    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.)


Estimated Enrollment: 16000
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound scan
The group is pregnant women who reside in an intervention cluster who receive at least one ultrasound scan during antenatal care during the study time period.
Device: Antenatal Ultrasound Scan
Women in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications.
No Intervention: Routine antenatal care
The group is pregnant women that reside in the control clusters during the study time period.

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

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women who provide consent
  • Resident of study cluster
  • Enrolled/eligible for the Global Network Maternal and Neonatal Health Registry
  • Women ≥ 18 weeks gestation at enrollment

Exclusion Criteria:

- Women who are in labor at time of consent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990625

Contacts
Contact: Elizabeth McCure, PhD 919-316-3773 mcclure@rti.org
Contact: Robert Goldenberg, MD rlg88@columbia.edu

Locations
Congo
Kinshasa School of Public Health Not yet recruiting
Gemena, Equateur, Congo
Contact: Antoinette Tshefu, M.D.         
Principal Investigator: Carl Bose, M.D.         
Guatemala
IMSALUD / San Carlos University Not yet recruiting
Guatemala City, Guatemala
Contact: Ana Garcés, MD, MPH    011 (502) 2332-4064    anagarces@imsalud.org   
Contact: Michael Hambidge, MD    (303) 724-3261    michael.hambidge@uchsc.edu   
Principal Investigator: Ana Garces, MD         
Kenya
Moi University School of Medicine Recruiting
Eldoret, Kenya, 30100
Contact: Fabian Esamai, MBChB, MMed, PhD    011 254 733 836 410    fesamai2007@gmail.com   
Contact: Ed Liechty, MD    317-274-4715    eliecht@iupui.edu   
Principal Investigator: Fabian Esamai, MBChB, MMed, PhD         
Pakistan
The Aga Khan University Recruiting
Karachi, Pakistan
Contact: Omrana Pasha, MD    011 (92-21) 486 4948    omrana.pasha@aku.edu   
Contact: Sarah Saleem, MD         
Principal Investigator: Sarah Saleem, MD         
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba    011 (260-211) 25-46-55    echomba@zamnet.zm   
Contact: Waldemar Carlo, MD    (205) 934-4680    Wcarlo@PEDS.UAB.EDU   
Principal Investigator: Elwyn Chomba, MD         
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Bill and Melinda Gates Foundation
GE Healthcare
  More Information

No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT01990625     History of Changes
Other Study ID Numbers: GN First Look Ultrasound
Study First Received: November 15, 2013
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Maternal Near Miss Morbidity
Maternal Mortality
Neonatal Mortality
Gestational Age Dating
Pregnancy Complications
Ultrasound
Stillbirth

Additional relevant MeSH terms:
Eclampsia
Fetal Growth Retardation
Placenta Previa
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Obstetric Labor Complications
Placenta Diseases

ClinicalTrials.gov processed this record on September 11, 2014