Original Articles

Clinical Validation of Mobile Cardiotocograph Device for Intrapartum and Antepartum Monitoring Compared to Standard Cardiotocograph: An Inter-Rater Agreement Study

Abstract

Objective: Electronic fetal monitoring (EFM) using cardiotocograph (CTG) is commonly used both to assess fetal wellbeing in late antepartum and for intervention during intrapartum period. We validated the performance of indigenously developed mobile cardiotocograph (CTG) device with wireless probes compared to standard CTG device.
Materials and methods: We sequentially used mobile and standard CTG devices in 495 pregnant women in labour and 359 pregnant women with gestation > 32 weeks. The CTG interpreted by two independent obstetricians in a blinded manner were compared to estimate the agreement by kappa (k) statistic.
Results: High level of agreements between mobile and standard CTG devices for both intrapartum (87.9%; kappa 0.61) and antepartum monitoring (91.2%; kappa 0.60) were observed. Most of the pregnant women (80% in intrapartum and 70% in antepartum groups) and all nurses and obstetricians preferred the mobile CTG device over standard CTG device.
Conclusion: The mobile CTG device can reliably be used for both intrapartum and antepartum monitoring instead of the standard CTG devices. The smaller size, portability and ability to transmit the recordings for second opinion make it suitable for use by midwives for appropriate triaging and referral. Wider availability of CTG and interpretation support at the peripheral facilities would assist identifying at-risk pregnancies and foetuses for timely referral and appropriate action to reduce perinatal deaths, stillbirths and birth asphyxi.

1. Blencowe H, Cousens S, Jassir FB, Say L, Chou D, Mathers C, et al. Lancet stillbirth epidemiology investigator group. National, regional, and worldwide estimates of stillbirth rates in 2015, with trends from 2000: a systematic analysis. Lancet Glob Health 2016; 4:e98-e108.
2. Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, et al. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet 2016; 388:3027-35.
3. Ministry of Health and Family Welfare, Government of India. INAP: India new-born action plan. New Delhi: Government of India, 2014.
4. Alfirevic Z, Gyte GML, Cuthbert A, Devane D. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database of Systematic Reviews, 2017.
5. Palomäki O, Luukkaala T, Luoto R, Tuimala R. Intrapartum cardiotocography -- the dilemma of interpretational variation. J Perinat Med 2006; 34:
298-302.
6. Schiermeier S, Pildner von Steinburg S, Thieme A, Reinhard J, Daumer M, Scholz M, et al. Sensitivity and specificity of intrapartum computerised FIGO criteria for cardiotocography and fetal scalp pH during labour: multicentre, observational study. BJOG 2008; 115:1557-63.
7. Abed G Nagure, Umashankar K. M, Dharmavijay M. N, Mahe Darakshan. M. Saleem. Admission cardiotocography: Its role in predicting foetal outcome in high-risk obstetric patient. Indian Journal of Basic and Applied Medical Research2013; 3:156–64.
8. Behuria S, Nayak R. Admission cardiotocography as a screening test in high risk pregnancies and its co-relation with peri-natal outcome. International Journal of Reprodtion Contraception Obstetrics Gynecology 2016; 5: 3525–8.
9. Rahman H, Renjhen P, Dutta S, Kar S. Admission cardiotocography: Its role in predicting foetal outcome in high-risk obstetric patients. Australas Med J 2012; 5: 522-7.
10. Kansal R, Goel G, Mangla D, Garg P, Verma K, Geetika. Correlation of admission test with neonatal outcome. People’s Journal of Scientific Research 2014; 7: 27–31.
11. Sandhu G S, Raju R, Bhattacharya T K, Shaktivardhan. Admission cardiotocography screening of high risk obstetric patients. Med J Armed Forces India 2008; 64: 43–5.
12. Valerie Smith, Cecily M Begley, Mike Clarke, Declan Devane. Professionals’ views of fetal monitoring during labour: a systematic review and thematic analysis. BMC Pregnancy Childbirth 2012; 12: 166.
13. Luka´s Zachˇ, Vaclav Chud´ a´cekˇ, Jakub Kuzˇ´ılek1, Jiˇr´ı Spilka1, Michal Huptych1, Miroslav Bursaˇ, et al. Mobile CTG – fetal heart rate assessment using android platform. Computing in Cardiology 2011; 38: 249−52.
14. Signorini MG, Fanelli A, Magenes G. Monitoring fetal heart rate duringpregnancy: contributions from advanced signal processing and wearable technology. Comput Math Methods Med 2014; 2014: 1–10.
15. Su CJ, Chu TW. A mobile multi-agent information system for ubiquitous fetal monitoring. Int J Environ Res Public Health 2014; 11:600-25.
16. Saving Lives at Birth: A Grand challenge for development, 2017.
17. Cohen J. A coefficient of agreement for nominal scales. Educational and Psychological Measurement 1960; 20: 37–46.
18. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159-74.
19. Feinstein AR, Cicchetti DV. High agreement but low kappa: I. The problems of two paradoxes. J Clin Epidemiol 1990; 43: 543-9.
20. Cicchetti DV, Feinstein AR. High agreement but low kappa: II. Resolving the paradoxes. J Clin Epidemiol 1990; 43: 551-8.
21. Rivenes Lafontan S, Sundby J, Ersdal H, Abeid M, Kidanto H, Mbekenga C. “I was relieved to know that my baby was safe”: Women’s attitudes and perceptions on using a New Electronic Fetal Heart Rate Monitor during Labor in Tanzania. Int J Environ Res Public Health 2018; 15: E302.
Files
IssueVol 13, No 2 (June 2019) QRcode
SectionOriginal Articles
DOI https://doi.org/10.18502/jfrh.v13i2.1918
Keywords
Wireless Cardiotocograph Fetal Heart Rate Uterine Contraction Intrapartum Monitoring Agreement Acceptability

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
1.
Das M, Tripathi R, Kashyap N, Fotedar S, Bisht S, Rathore A, Raghav A. Clinical Validation of Mobile Cardiotocograph Device for Intrapartum and Antepartum Monitoring Compared to Standard Cardiotocograph: An Inter-Rater Agreement Study. J Family Reprod Health. 2019;13(2):109-115.