Routine antenatal ultrasound in low‐ and middle‐income countries: first look – a cluster randomised trial

Goldenberg, Renato; Nathan, R.; Swanson, David L.; Saleem, Sarah; Mirza, Waseem; Esamai, Fabian; Muyodi, David; Garces, AL; Figueroa, Lester; Chomba, Elwyn; Chiwala, M; Mwenechanya, Musaku; Tshefu, Antoinette; Lokangako, A; Bolamba, VL; Moore, Janet; Franklin, Holly; Swanson, Jonathan O.; Liechty, E. A.; Bose, Christine E.; Nf, Krebs; Hambidge, K. Michael; Carlo, Waldemar F.; Kanaiza, Nancy; Naqvi, Farnaz; Pineda, IS; López-Gomez, Walter; Hamsumonde, Dorothy; Harrison,; Koso‐Thomas, Marion; Miodovnik, Menachem; Wallace, D. D.; McClure, EM

doi:10.1111/1471-0528.15287

Cited by 73 publications

(90 citation statements)

References 39 publications

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“…At present the only way to determine the fetal growth rate at primary care level in SA is by measuring the SF height. A recent study of two-stage routine ultrasound scanning in LMICs found no effect on stillbirths or neonatal mortality or an increase in antenatal attendance, [20] seriously calling into question the role of routine ultrasound in preventing perinatal deaths. Screening using continuous-wave Doppler ultrasound may be much more useful than conventional ultrasound and SF measurements in detecting fetuses at risk of stillbirth.…”

Section: Discussionmentioning

confidence: 99%

Screening and managing a low-risk pregnant population using continuous-wave Doppler ultrasound in a low-income population: A cohort analytical study

et al. 2019

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Background. In South Africa (SA), the largest category of perinatal deaths is unexplained stillbirths. Two-thirds of these occur in the antenatal period and most fetuses are macerated, but at antenatal clinics the mothers were generally regarded as healthy, with low-risk pregnancies. Innovative methods are urgently required to detect fetuses at risk of stillbirth and manage the mothers appropriately. Objectives. To determine the prevalence of raised resistance indices (RIs) of the umbilical artery in a low-risk, low-income population and ascertain whether use of this information can prevent perinatal deaths. Methods. A descriptive study was performed in Mamelodi township, east of Pretoria, SA, on pregnant women attending antenatal clinics draining to two community health centres (CHCs). These women, classified as having low-risk pregnancies, were screened for placental insufficiency using a continuous-wave Doppler ultrasound apparatus (Umbiflow) between 28 and 32 weeks' gestation. When a raised RI was detected, the mother was referred to a high-risk clinic and managed according to a standard protocol. A cohort analytical study compared women who attended antenatal care at the same clinics as the Umbiflow group but did not have an Umbiflow test with those who had an Umbiflow test. The outcomes of all the deliveries in Mamelodi were recorded. The prevalences of abnormal RIs, absent end-diastolic flow (AEDF), stillbirths and neonatal deaths were the main outcome measures.Results. An Umbiflow RI was performed in 2 868 women, and pregnancy outcome was available for 2 539 fetuses (88.5%); 297 fetuses (11.7%) were regarded as at high risk. AEDF was found in 1.5% of the population screened with an outcome. There were 29 perinatal deaths in the Umbiflow group (low risk n=18, high risk n=11). The perinatal mortality rate for 12 168 women attending the CHCs and the antenatal clinics draining to the CHCs who did not have an RI was 21.3/1 000 births, significantly higher than that in the Umbiflow group (11.4/1 000 births) (risk ratio 0.58, 95% confidence interval 0.42 -0.81). Conclusions. The prevalence of AEDF in this low-risk population is ~10 times higher than that previously recorded. Use of the information prevented a number of perinatal deaths, most of which would have been macerated stillbirths. Screening a low-risk pregnant population using continuous-wave Doppler ultrasound may substantially reduce the prevalence of unexplained stillbirths in SA.

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Section: Discussionmentioning

confidence: 99%

Screening and managing a low-risk pregnant population using continuous-wave Doppler ultrasound in a low-income population: A cohort analytical study

et al. 2019

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“…The data were all collected prospectively. Every case in which oligohydramnios was diagnosed was also confirmed by a radiologist with extensive expertise in ultrasonography in pregnancy [18][19][20][21]. Outcome data were collected independently from the ultrasound study team as part of an ongoing pregnancy outcome registry.…”

Section: Discussionmentioning

confidence: 99%

“…To address this need, we conducted a secondary analysis of data from the First Look Trial, which aimed to determine if the introduction of ultrasound examinations during antenatal care in low-resource settings improved maternal mortality, maternal near-miss mortality, stillbirth and neonatal mortality. The methods and results of the parent trial have been published [17,18]. Our objectives in conducting this planned secondary analysis included determining the prevalence of oligohydramnios, risk factors for this condition, and the maternal and fetal outcomes associated with oligohydramnios in LMIC settings.…”

Section: Introductionmentioning

confidence: 99%

Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries

et al. 2020

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Background: Oligohydramnios is a condition of abnormally low amniotic fluid volume that has been associated with poor pregnancy outcomes. To date, the prevalence of this condition and its outcomes has not been well described in low and low-middle income countries (LMIC) where ultrasound use to diagnose this condition in pregnancy is limited. As part of a prospective trial of ultrasound at antenatal care in LMICs, we sought to evaluate the incidence of and the adverse maternal, fetal and neonatal outcomes associated with oligohydramnios. Methods: We included data in this report from all pregnant women in community settings in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo (DRC) who received a third trimester ultrasound as part of the First Look Study, a randomized trial to assess the value of ultrasound at antenatal care. Using these data, we conducted a planned secondary analysis to compare pregnancy outcomes of women with to those without oligohydramnios. Oligohydramnios was defined as measurement of an Amniotic Fluid Index less than 5 cm in at least one ultrasound in the third trimester. The outcomes assessed included maternal morbidity and fetal and neonatal mortality, preterm birth and low-birthweight. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models using general estimating equations to account for the correlation of outcomes within cluster.Results: Of 12,940 women enrolled in the clusters in Guatemala, Pakistan, Zambia and the DRC in the First Look Study who had a third trimester ultrasound examination, 87 women were diagnosed with oligohydramnios, equivalent to 0.7% of those studied. Prevalence of detected oligohydramnios varied among study sites; from the lowest of 0.2% in Zambia and the DRC to the highest of 1.5% in Pakistan. Women diagnosed with oligohydramnios had higher rates of hemorrhage, fetal malposition, and cesarean delivery than women without oligohydramnios. We also found unfavorable fetal and neonatal outcomes associated with oligohydramnios including stillbirths (OR 5.16, 95%CI 2.07, 12.85), neonatal deaths < 28 days (OR 3.18, 95% CI 1.18, 8.57), low birth weight (OR 2.10, 95% CI 1.44, 3.07) and preterm births (OR 2.73, 95%CI 1.76, 4.23). The mean birth weight was 162 g less (95% CI -288.6, − 35.9) with oligohydramnios. Conclusions:Oligohydramnos was associated with worse neonatal, fetal and maternal outcomes in LMIC. Further research is needed to assess effective interventions to diagnose and ultimately to reduce poor outcomes in these settings.Trial registration: NCT01990625.

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“…While the use of conventional ultrasound diagnostics is a routine component of antenatal care in high-income countries, in many low-and middle-income countries (LMICs), the only way to determine fetal growth rate at the primary care level is by palpation and measuring the symphysis fundal height (SFH) using tape measure [6]. Small studies in LMICs have shown that the use of the conventional ultrasound directly in uences antenatal care (ANC) utilization, improving referral for detected conditions and gestational age dating, and increasing the use of hospital for deliveries [7]. However, Goldenberg et al [7] in their cluster randomized trial, concluded that routine conventional ultrasound found no effect on ANC attendance, reduction in maternal, stillbirth or neonatal mortality.…”

Section: Introductionmentioning

confidence: 99%

“…Small studies in LMICs have shown that the use of the conventional ultrasound directly in uences antenatal care (ANC) utilization, improving referral for detected conditions and gestational age dating, and increasing the use of hospital for deliveries [7]. However, Goldenberg et al [7] in their cluster randomized trial, concluded that routine conventional ultrasound found no effect on ANC attendance, reduction in maternal, stillbirth or neonatal mortality. Furthermore, it seems to contribute to the improvement of patient management and the con rmation of clinically suspected obstetric complications [8].…”

Section: Introductionmentioning

confidence: 99%

Portable Continuous Wave Doppler Ultrasound for Primary Healthcare in South Africa: Can the EUnetHTA Core Model Guide Evaluation Before Technology Adoption?

Mueller¹,

Pattinson

Hlongwane

et al. 2020

Preprint

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Background: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce the evidence gaps and interpret findings; applicability of the EUnetHTA Core Model (CM) in South Africa on a medical device and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound.Methods: To substantiate the evidence obtained from the literature different stakeholders were identified and consulted. The scoping of the assessment was defined by involving the policy makers to select the domains and the analogous questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. The evidence generated from the four steps was used to populate the high-ranked assessment elements of the CM. Results: The HTA took into account the clinical benefit in screening low-risk pregnant women in primary healthcare settings using the technology. It incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on “health problem” and “safety” had a higher rank than the rest of the nine domains. Conclusions: A multi-stakeholder participation in the assessment process provided the necessary transparency and accountability, thus improving the quality of the recommendation resulting from the assessment. The collection of robust evidence and analysis post-introduction will enable the determination of the value of the technology in real-world settings.

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Routine antenatal ultrasound in low‐ and middle‐income countries: first look – a cluster randomised trial

Abstract: Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.

Cited by 73 publications

References 39 publications

Screening and managing a low-risk pregnant population using continuous-wave Doppler ultrasound in a low-income population: A cohort analytical study

Screening and managing a low-risk pregnant population using continuous-wave Doppler ultrasound in a low-income population: A cohort analytical study

Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries

Portable Continuous Wave Doppler Ultrasound for Primary Healthcare in South Africa: Can the EUnetHTA Core Model Guide Evaluation Before Technology Adoption?

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