BMC public health · 2025
Effectiveness of a mobile cardiotocography device (iCTG) in improving antenatal care and detecting abnormal fetal heart rate during late pregnancy: an implementation study in Tanzania.
СтатьяPragmatic Clinical TrialНазвание и аннотация: Перевод в очереди
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Mwakawanga Dorkasi L, Chen Sanmei, Patil Crystal L, Rahman Md Moshiur, Mwilike Beatrice, Massae Agnes F, Hirose Naoki, Kobayashi Yuryon, Shimpuku Yoko
Аннотация
BACKGROUND: In Tanzania, 35% of pregnant women fail to complete four antenatal care (ANC) visits, increasing their risk for pregnancy-related complications, maternal mortality, and stillbirth. We evaluated the effectiveness of a Mobile Fetal Heart Monitor (Melody International Ltd, iCTG) device in improving pregnancy and childbirth outcomes in Tanzania.
METHODS: We used a pragmatic, non-randomized clinical trial to evaluate the effectiveness of the 8-month implementation of iCTG. Pregnant women at 32 gestational age or above were monitored using iCTG in intervention facilities (n = 492), while control facilities (n = 271) continued standard care. The primary outcome was the completion of ≥ 4 ANC visits, with secondary outcomes including abnormal fetal heart rate (FHR) detection, birth method, institutional births, Apgar scores, and perinatal outcomes. Binary, multinomial, and Poisson regression models were used to determine the intervention effect.
RESULTS: iCTG users were twice as likely to complete fewer than 4 ANC visits (OR: 2.5, 95% CI: 1.28-4.75, p = 0.007). However, iCTG was associated with higher abnormal FHR detection rates (8.08, 95% CI: 2.51-26.02; p < 0.001), increased risk of caesarean section (p < 0.001), reduced risk for Apgar scores < 7 at 5 min (p = 0.024) and fewer perinatal deaths (p = 0.003). There were no significant differences in newborn admission (p = 0.41) or institutional births (p = 0.26).
CONCLUSION: Implementing iCTG for antepartum FHR monitoring effectively detected abnormal FHR and was associated with improved newborn outcomes, highlighting its potential to improve perinatal outcomes in Tanzania. However, no effect was found on the number of ANC visits and institutional births. Further studies are needed to assess the effectiveness of iCTG in diverse populations and contexts and identify key factors for optimal implementation.
TRIAL REGISTRATION: The study was registered in the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (ID: UMIN000051932) on 18 August 2023. ( https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058801 ).
METHODS: We used a pragmatic, non-randomized clinical trial to evaluate the effectiveness of the 8-month implementation of iCTG. Pregnant women at 32 gestational age or above were monitored using iCTG in intervention facilities (n = 492), while control facilities (n = 271) continued standard care. The primary outcome was the completion of ≥ 4 ANC visits, with secondary outcomes including abnormal fetal heart rate (FHR) detection, birth method, institutional births, Apgar scores, and perinatal outcomes. Binary, multinomial, and Poisson regression models were used to determine the intervention effect.
RESULTS: iCTG users were twice as likely to complete fewer than 4 ANC visits (OR: 2.5, 95% CI: 1.28-4.75, p = 0.007). However, iCTG was associated with higher abnormal FHR detection rates (8.08, 95% CI: 2.51-26.02; p < 0.001), increased risk of caesarean section (p < 0.001), reduced risk for Apgar scores < 7 at 5 min (p = 0.024) and fewer perinatal deaths (p = 0.003). There were no significant differences in newborn admission (p = 0.41) or institutional births (p = 0.26).
CONCLUSION: Implementing iCTG for antepartum FHR monitoring effectively detected abnormal FHR and was associated with improved newborn outcomes, highlighting its potential to improve perinatal outcomes in Tanzania. However, no effect was found on the number of ANC visits and institutional births. Further studies are needed to assess the effectiveness of iCTG in diverse populations and contexts and identify key factors for optimal implementation.
TRIAL REGISTRATION: The study was registered in the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (ID: UMIN000051932) on 18 August 2023. ( https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058801 ).