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

NCT01990625 | Completed DMC

• 1 other identifier: GN First Look Ultrasound
• Study Type: interventional
• Target: 45,038
• Locations: 5 countries
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• Composite outcome

  Introduction of ultrasound will decrease the composite outcome of maternal mortality and near miss maternal mortality events and stillbirths plus early neonatal mortality.

  Up to 30 months

Secondary Outcomes (1)

• Rate of Women with Complicated Deliveries at Health Facilities

  Up to 30 months

Other Outcomes (1)

• Antenatal Care Utilization

  Up to 30 months

Study Arms (2)

Ultrasound scan

EXPERIMENTAL

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.

Device: Antenatal Ultrasound Scan

Routine antenatal care

NO INTERVENTION

The group is pregnant women that reside in the control clusters during the study time period. The group received routine antenatal care.

Interventions

Antenatal Ultrasound Scan DEVICE

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

Ultrasound scan

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Women who are in labor at time of consent

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Bill and Melinda Gates Foundation: collaborator
• GE Healthcare: collaborator

Study Sites (5)

IMSALUD / San Carlos University

Guatemala City, Guatemala

Location

Moi University School of Medicine

Eldoret, 30100, Kenya

Location

The Aga Khan University

Karachi, Pakistan

Location

Kinshasa School of Public Health

Gemena, Equateur, Republic of the Congo

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (6)

• Nathan R, Swanson JO, Marks W, Goldsmith N, Vance C, Sserwanga NB, Swanson D, McClure EM, Franklin H, Mirza W, Mwenechanya M, Muyodi D, Figuero L, Bolamba VL, Goldenberg RL, Pineda IS. Screening obstetric ultrasound training for a 5-country cluster randomized controlled trial. Ultrasound Q. 2014 Dec;30(4):262-6. doi: 10.1097/RUQ.0000000000000096.

  PMID: 25415862 BACKGROUND

• McClure EM, Nathan RO, Saleem S, Esamai F, Garces A, Chomba E, Tshefu A, Swanson D, Mabeya H, Figuero L, Mirza W, Muyodi D, Franklin H, Lokangaka A, Bidashimwa D, Pasha O, Mwenechanya M, Bose CL, Carlo WA, Hambidge KM, Liechty EA, Krebs N, Wallace DD, Swanson J, Koso-Thomas M, Widmer R, Goldenberg RL. First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings. BMC Pregnancy Childbirth. 2014 Feb 17;14:73. doi: 10.1186/1471-2393-14-73.

  PMID: 24533878 BACKGROUND

• Bresnahan BW, Vodicka E, Babigumira JB, Malik AM, Yego F, Lokangaka A, Chitah BM, Bauer Z, Chavez H, Moore JL, Garrison LP, Swanson JO, Swanson D, McClure EM, Goldenberg RL, Esamai F, Garces AL, Chomba E, Saleem S, Tshefu A, Bose CL, Bauserman M, Carlo W, Bucher S, Liechty EA, Nathan RO. Cost estimation alongside a multi-regional, multi-country randomized trial of antenatal ultrasound in five low-and-middle-income countries. BMC Public Health. 2021 May 20;21(1):952. doi: 10.1186/s12889-021-10750-8.

  PMID: 34016085 DERIVED

• Figueroa L, McClure EM, Swanson J, Nathan R, Garces AL, Moore JL, Krebs NF, Hambidge KM, Bauserman M, Lokangaka A, Tshefu A, Mirza W, Saleem S, Naqvi F, Carlo WA, Chomba E, Liechty EA, Esamai F, Swanson D, Bose CL, Goldenberg RL. Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries. Reprod Health. 2020 Jan 30;17(1):19. doi: 10.1186/s12978-020-0854-y.

  PMID: 32000798 DERIVED

• Bauserman M, Nathan R, Lokangaka A, McClure EM, Moore J, Ishoso D, Tshefu A, Figueroa L, Garces A, Harrison MS, Wallace D, Saleem S, Mirza W, Krebs N, Hambidge M, Carlo W, Chomba E, Miodovnik M, Koso-Thomas M, Liechty EA, Esamai F, Swanson J, Swanson D, Goldenberg RL, Bose C. Polyhydramnios among women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries: a secondary analysis of the first look study. BMC Pregnancy Childbirth. 2019 Jul 22;19(1):258. doi: 10.1186/s12884-019-2412-6.

  PMID: 31331296 DERIVED

• Franklin HL, Mirza W, Swanson DL, Newman JE, Goldenberg RL, Muyodi D, Figueroa L, Nathan RO, Swanson JO, Goldsmith N, Kanaiza N, Naqvi F, Pineda IS, Lopez-Gomez W, Hamsumonde D, Bolamba VL, Fogleman EV, Saleem S, Esamai F, Liechty EA, Garces AL, Krebs NF, Michael Hambidge K, Chomba E, Mwenechanya M, Carlo WA, Tshefu A, Lokangaka A, Bose CL, Koso-Thomas M, Miodovnik M, McClure EM. Factors influencing referrals for ultrasound-diagnosed complications during prenatal care in five low and middle income countries. Reprod Health. 2018 Dec 12;15(1):204. doi: 10.1186/s12978-018-0647-8.

  PMID: 30541560 DERIVED

MeSH Terms

Conditions

Eclampsia; Placenta Previa; Stillbirth; Fetal Growth Retardation; Maternal Death; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Placenta Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Parental Death

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

GU (1); KE (1); PA (1); RE (1); ZA (1)