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.
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| Title: | 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. |
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| Authors: | Mwakawanga DL; Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 730-0045, Japan.; Department of Midwifery, Child and Reproductive Health, School of Nursing, Muhimbili University of Health and Allied Sciences, P. O Box 65001, Dar es Salaam, Tanzania., Chen S; Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 730-0045, Japan., Patil CL; University of Michigan, 400 N Ingalls Street, Ann Arbor, MI, 48109, USA., Rahman MM; Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 730-0045, Japan., Mwilike B; Department of Midwifery, Child and Reproductive Health, School of Nursing, Muhimbili University of Health and Allied Sciences, P. O Box 65001, Dar es Salaam, Tanzania., Massae AF; Department of Midwifery, Child and Reproductive Health, School of Nursing, Muhimbili University of Health and Allied Sciences, P. O Box 65001, Dar es Salaam, Tanzania., Hirose N; Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 730-0045, Japan., Kobayashi Y; Translational Research Center Biodesign Team, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan., Shimpuku Y; Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 730-0045, Japan. yokoshim@hiroshima-u.ac.jp. |
| Source: | BMC public health [BMC Public Health] 2025 Nov 26; Vol. 25 (1), pp. 4150. Date of Electronic Publication: 2025 Nov 26. |
| Publication Type: | Journal Article; Pragmatic Clinical Trial |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : BioMed Central, [2001- |
| MeSH Terms: | Prenatal Care*/methods , Prenatal Care*/standards , Prenatal Care*/statistics & numerical data , Cardiotocography*/instrumentation , Heart Rate, Fetal*/physiology, Humans ; Female ; Pregnancy ; Tanzania ; Adult ; Pregnancy Outcome ; Young Adult |
| Abstract: | Competing Interests: Declarations. Ethics approval and consent to participate: The study was performed accordance to the ethical standards of the Helsink Declaration of 1975. The National Institute for Medical Research, Tanzania (NIMR/HQ/R.8a/Vol.IX/4341) and the Institutional Review Board of Hiroshima University, Japan (C2023-0008) granted ethical approvals for this study. The study was conducted based on ethical principles such as harmlessness, anonymity, and protecting the privacy and personal information of study participants. Written informed consent was obtained from each participant to participate in the study after being provided with adequate information regarding the aim of the study. All participants were briefed that taking part in the study was voluntary and that they were free to decline or withdraw at any time during the study. Consent for publication: Not applicable. Competing interests: Melody International, Ltd. (Takamatsu, Kagawa, Japan) provided the iCTG devices free of charge for this study. 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 ). (© 2025. The Author(s).) |
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| Grant Information: | JP23hk0302012). Japan Agency for Medical Research and Development |
| Contributed Indexing: | Keywords: Abnormal fetal heart rate; Antenatal care; Implementation; Late pregnancy; Tanzania; iCTG |
| Entry Date(s): | Date Created: 20251127 Date Completed: 20251127 Latest Revision: 20251129 |
| Update Code: | 20251129 |
| PubMed Central ID: | PMC12659349 |
| DOI: | 10.1186/s12889-025-25383-4 |
| PMID: | 41299386 |
| Database: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Competing Interests: Declarations. Ethics approval and consent to participate: The study was performed accordance to the ethical standards of the Helsink Declaration of 1975. The National Institute for Medical Research, Tanzania (NIMR/HQ/R.8a/Vol.IX/4341) and the Institutional Review Board of Hiroshima University, Japan (C2023-0008) granted ethical approvals for this study. The study was conducted based on ethical principles such as harmlessness, anonymity, and protecting the privacy and personal information of study participants. Written informed consent was obtained from each participant to participate in the study after being provided with adequate information regarding the aim of the study. All participants were briefed that taking part in the study was voluntary and that they were free to decline or withdraw at any time during the study. Consent for publication: Not applicable. Competing interests: Melody International, Ltd. (Takamatsu, Kagawa, Japan) provided the iCTG devices free of charge for this study.<br />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.<br />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.<br />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).<br />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.<br />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 ).<br /> (© 2025. The Author(s).) |
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| ISSN: | 1471-2458 |
| DOI: | 10.1186/s12889-025-25383-4 |