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Table 1 Quality Assessment of Studies related to Outcome Measures

From: Obstetric ultrasound use in low and middle income countries: a narrative review

Author, Year

Location

Study Period

Type of Ultrasound

Study Description

Key Points

Sample Size

Funding or Support

Ross AB, DeStigter KK, Rielly M, Souza S, Morey GE, Nelson M, et al. 2013 [23]

Uganda

2 years

Low cost, portable ultrasound machines

Quantitative study - no control group included. Historical control data was used as a comparison.

Women received ultrasound scan at the first ANC visit and at 32 weeks gestation. Based on need, ultrasound scans were performed at other ANC visits as well.

Two midwives at the study health center were trained for 3 days. Training included classroom and hands-on sessions with a competency assessment.

The focus of the program was on diagnosing multiple gestations, sequelae of abortion, causes of obstructed labor and placenta previa.

Total antenatal care visits significantly increased from 133.5 visits to 230.3 visits.

The number of first antenatal care visits increased from 82.2 visits to 119.1 visits.

The number of second antenatal care visits increased from 35.6 visits to 60.4 visits.

The number of third antenatal care visits increased from 11.6 visits to 31.9 visits.

The number of fourth antenatal care visits increased from 4.1 visits to 19.0 visits.

The average number of deliveries at the health center significantly increased from 28.1 deliveries to 45.6 deliveries.

Prior to introduction of ultrasound:

Antenatal visits

(n = 41)

Attended deliveries (n = 23)

After introduction of ultrasound:

Antenatal visits

(n = 23)

Attended deliveries (n = 23)

Imaging the World (received funding from the Fineberg Foundation, the Bill and Melinda Gates Foundation, Phillips Health Care, McKesson Corporation, Peervue Corporation).

Research project was also supported by an Alpha Omega Alpha postgraduate award.

Mbuyita S, Tillya R, Godfrey R, Kinyonge I, Shaban J, Mbaruku G, 2015 [25]

Tanzania

1 year

Portable hand-held Vscan

Quantitative and Qualitative study - Before and After design with intervention and control groups.

Portable handheld ultrasound technology (Vscan) was introduced in routine ANC services.

Assistant medical officers at the health center level and mid-level providers (clinical officers, nurse midwives and medical attendants) at the dispensary level were trained to use the Vscan ultrasound in routine ANC services.

Between baseline and endline periods in the intervention area:

The number of first antenatal care visits did not change significantly.

The number of four or more antenatal care visits increased significantly.

The number of facility deliveries increased significantly.

Intervention arm:

Baseline (n = 381)

Endline (n = 423)

Control arm:

Baseline (n = 394)

Endline (n = 383)

GE Healthcare East Africa Services Limited supported the project

Van Dyk B, Motto JA and Buchmann EJ, 2007 [19]

South Africa

Not Mentioned

Not Mentioned

Quantitative study - cluster-randomized controlled trial. Control group of no ultrasound was included.

Routine second-trimester ultrasound scans were performed by an experienced licensed ultrasonographer to women with low risk pregnancies at 18–23 weeks by clinical estimation.

Routine second-trimester ultrasound scanning did not result in a significant difference in perinatal mortality between the ultrasound scan group and the control group. However, sample size was insufficient.

Intervention group (n = 416)

Control group (n = 388)

Not Mentioned

Geerts LT, Brand EJ and Theron GB, 1996 [22]

South Africa

10 months

Aloka SSD-500, SSD-620, SSD-650, with 3.5 MHz curvilinear electronic probes.

Quantitative study - randomized controlled trial. Control group of selective ultrasound compared to the intervention group of routine ultrasound.

“Pregnant patients without risk factors for congenital anomalies referred for ultrasonography between 18 and 24 weeks of gestation” participated in the study.

Women in the intervention group received “a single level one ultrasound exam performed by obstetric registrars or medical officers specifically trained in obstetric ultrasound.”

The difference in perinatal mortality between the intervention and control groups was not statistically significant.

There was not enough sample size to detect differences in perinatal mortality alone.

However, when combined with major morbidities, there was a significant increase (25%) in total adverse perinatal outcomes in the control group without routine ultrasonography.

Intervention group (n = 496)

Control group (n = 492)

Not Mentioned

McClure E, Goldenberg R, Swanson D, Saleem S, Esamai F, Garces A, et al. 2017 [20]

Pakistan, Kenya, Zambia, Democratic Republic of Congo, Guatemala

18 months

Ultrasound equipment donated by GE Healthcare

Quantitative study - cluster randomized trial.

Clusters were randomized either to the control group of usual care or to the intervention group of receiving ultrasound at 16–22 and 32–36 weeks and appropriate referrals.

Multiple intervention components were included:

Two-week obstetric ultrasound training for varying cadres of non-physician health workers.

3-month pilot period and follow-up quality assurance system to ensure successful implementation.

Training for referral facility staff in management of major obstetric and neonatal conditions.

Meetings with ministry of health officials and hospital administrators in order to improve health system management.

Community orientations in order to raise awareness about the availability of service and the purpose of ultrasound.

There was no difference in primary composite outcome, stillbirth rate, neonatal mortality rate, near miss rate, maternal death, at least one antenatal visit, four or more antenatal visits and delivery at the hospital with cesarean section capacity between the intervention and control groups.

78% of deliveries in the intervention group received one or more ultrasound service and 60% received two ultrasound services.

9% of women were referred based on ultrasound diagnosis and 71% followed up with the referrals.

Guatemala (18 clusters)

Zambia (10 clusters)

Kenya (12 clusters)

Pakistan (10 clusters)

Democratic Republic of the Congo (8 clusters)

Trial funded by Bill & Melinda Gates Foundation. The ultrasound trial conducted by Global Network for Women’s and Children’s Health Research (supported by Eunice Kennedy Shriver National Institute of Child Health and Human Development). Obstetric ultrasound training oversight by The University of Washington Department of Radiology with support from GE Healthcare

Ross AB, DeStigter KK, Coutinho A, Souza S, Mwatha A, Matovu A, et al. 2014 [26]

Uganda

2 years

Low cost, portable ultrasound machines

Quantitative study - no control group included. Historical control data was used as a comparison.

Women received ultrasound scan at the first ANC visit and at 32 weeks gestation. Based on need, ultrasound scans were performed at other ANC visits as well.

Two midwives at the study health center were trained for 3 days. Training included classroom and hands-on sessions with a competency assessment.

The focus of the program was on diagnosing multiple gestations, sequelae of abortion, causes of obstructed labor and placenta previa.

Comparing post-intervention ultrasound group to pre-intervention historical control:

The relative rate ratios for anemia treatment, RR = 1.26 (1.15–1.38); deworming treatment, RR = 1.21 (1.11–1.32); and IPT2 treatment, RR = 2.13 (1.35–3.35) were all significantly higher than 1.

The relative rate ratio for HIV testing was not statistically significant and the relative rate ratio for IPT1 treatment, RR = 0.88 (0.79–0.98) was significantly lower than 1.

Prior to introduction of ultrasound:

Anemia – 34 months

Deworming – 34 months

HIV testing – 24 months

IPT1–40 months

IPT2–36 months

After introduction of ultrasound:

Anemia – 22 months

Deworming – 23 months

HIV testing – 23 months

IPT1–23 months

IPT2–23 months

Study supported by Bill and Melinda Gates Foundation, Sanofi, Philips Healthcare, McKesson Corporation and the Fineberg Foundation