Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania

Benjamin Kamala, Hussein Kidanto, Ingvild Dalen, Matilda Ngarina, Muzdalifat Abeid, Jeffrey Perlman, Hege Ersdal, Benjamin Kamala, Hussein Kidanto, Ingvild Dalen, Matilda Ngarina, Muzdalifat Abeid, Jeffrey Perlman, Hege Ersdal

Abstract

Background: Intrapartum foetal heart rate (FHR) monitoring is crucial for identification of hypoxic foetuses and subsequent interventions. We compared continuous monitoring using a novel nine-crystal FHR monitor (Moyo) versus intermittent single crystal Doppler (Doppler) for the detection of abnormal FHR. Methods: An unmasked randomised controlled study was conducted in a tertiary hospital in Tanzania (ClinicalTrials.gov Identifier: NCT02790554). A total of 2973 low-risk singleton pregnant women in the first stage of labour admitted with normal FHR were randomised to either Moyo (n = 1479) or Doppler (1494) arms. The primary outcome was the proportion of abnormal FHR detection. Secondary outcomes were time intervals in labour, delivery mode, Apgar scores, and perinatal outcomes. Results: Moyo detected abnormal FHR more often (13.3%) compared to Doppler (9.8%) (p = 0.002). Time intervals from admission to detection of abnormal FHR were 15% shorter in Moyo (p = 0.12) and from the detection of abnormal FHR to delivery was 36% longer in Moyo (p = 0.007) compared to the Doppler arm. Time from last FHR to delivery was 12% shorter with Moyo (p = 0.006) compared to Doppler. Caesarean section rates were higher with the Moyo device compared to Doppler (p = 0.001). Low Apgar scores (<7) at the 1st and 5th min were comparable between groups (p = 0.555 and p = 0.800). Perinatal outcomes (fresh stillbirths and 24-h neonatal deaths) were comparable at delivery (p = 0.497) and 24-h post-delivery (p = 0.345). Conclusions: Abnormal FHR detection rates were higher with Moyo compared to Doppler. Moyo detected abnormal FHR earlier than Doppler, but time from detection to delivery was longer. Studies powered to detect differences in perinatal outcomes with timely responses are recommended.

Keywords: Doppler; Moyo; foetal heart rate; perinatal outcomes.

Conflict of interest statement

The authors have no conflicts of interest.

Figures

Figure 1
Figure 1
Moyo—the novel continuous FHR (foetal heart rate) monitor (Laerdal Global Health). * patient applied part.
Figure 2
Figure 2
The Moyo FHR monitor with a 30-minutes historical display (Laerdal Global Health).
Figure 3
Figure 3
Trial profile.
Figure 4
Figure 4
Flow diagrams of foetal heart rate (FHR) detections, mode of delivery, and perinatal outcomes in continuous Moyo and intermittent Doppler.

References

    1. UNICEF. WHO. World Bank Group. United Nations . Levels and Trends in Child Mortality Child Mortality. UNICEF; New York, NY, USA: 2017.
    1. Oza S., Cousens S.N., Lawn J.E. Estimation of daily risk of neonatal death, including the day of birth, in 186 countries in 2013: A vital-registration and modelling-based study. Lancet Glob. Heal. 2014;2:e635–e644. doi: 10.1016/S2214-109X(14)70309-2.
    1. Lawn J.E., Lee A.C.C., Kinney M., Sibley L., Carlo W.A., Paul V.K., Pattinson R., Darmstadt G.L. Two million intrapartum-related stillbirths and neonatal deaths: Where, why, and what can be done? Int. J. Gynaecol. Obstet. 2009 doi: 10.1016/j.ijgo.2009.07.016.
    1. Lawn J.E., Blencowe H., Oza S., You D., Lee A.C.C., Waiswa P., Lalli M., Bhutta Z., Barros A.J.D., Christian P., et al. Every Newborn: Progress, priorities, and potential beyond survival. Lancet. 2014;384:189–205. doi: 10.1016/S0140-6736(14)60496-7.
    1. Moshiro R., Perlman J.M., Kidanto H., Kvaløy J.T., Mdoe P., Ersdal H.L. Predictors of death including quality of positive pressure ventilation during newborn resuscitation and the relationship to outcome at seven days in a rural Tanzanian hospital. PLoS ONE. 2018;13:e0202641. doi: 10.1371/journal.pone.0202641.
    1. Ersdal H.L., Eilevstjønn J., Linde J.E., Yeconia A., Mduma E.R., Kidanto H., Perlman J. Fresh stillborn and severely asphyxiated neonates share a common hypoxic-ischemic pathway. Int. J. Gynecol. Obstet. 2018 doi: 10.1002/ijgo.12430.
    1. Nelson K.B., Sartwelle T.P., Rouse D.J. Electronic fetal monitoring, cerebral palsy, and caesarean section: Assumptions versus evidence. BMJ. 2016;355:i6405. doi: 10.1136/bmj.i6405.
    1. Van Handel M., Swaab H., de Vries L.S., Jongmans M.J. Behavioral Outcome in Children with a History of Neonatal Encephalopathy following Perinatal Asphyxia. J. Pediatr. Psychol. 2010;35:286–295. doi: 10.1093/jpepsy/jsp049.
    1. Alfirevic Z., Devane D., Gyte G.M., Cuthbert A. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst. Rev. 2017 doi: 10.1002/14651858.CD006066.pub3.
    1. Kamala B.A., Kidanto H.L., Wangwe P.J., Dalen I., Mduma E.R., Perlman J.M., Ersdal H.L. Intrapartum fetal heart rate monitoring using a handheld Doppler versus Pinard stethoscope: A randomized controlled study in Dar es Salaam. Int. J. Womens Health. 2018;10:341–348. doi: 10.2147/IJWH.S160675.
    1. Byaruhanga R., Bassani D.G., Jagau A., Muwanguzi P., Montgomery A.L., Lawn J.E. Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: A randomised clinical trial. BMJ Open. 2015;5:e006867. doi: 10.1136/bmjopen-2014-006867.
    1. NICE . Intrapartum Care for Healthy Women and Babies | Guidance and Guidelines | NICE. NICE; London, UK: 2017.
    1. American College of Obstetricians and Gynecologists ACOG Practice Bulletin No. 106: Intrapartum fetal heart rate monitoring: Nomenclature, interpretation, and general management principles. Obstet. Gynecol. 2009;114:192–202. doi: 10.1097/AOG.0b013e3181aef106.
    1. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists . The Royal Australian and New Zealand College of Obstetricians and Gynaecologists Intrapartum Fetal Surveillance Clinical Guideline—Third Edition 2014. 3rd ed. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists; Victoria, Australia: 2014.
    1. Kc A., Wrammert J., Clark R.B., Ewald U., Målqvist M. Inadequate fetal heart rate monitoring and poor use of partogram associated with intrapartum stillbirth: A case-referent study in Nepal. BMC Pregnancy Childbirth. 2016;16 doi: 10.1186/s12884-016-1034-5.
    1. Buchmann E.J., Velaphi S.C. Confidential enquiries into hypoxic ischaemic encephalopathy. Best Pract. Res. Clin. Obstet. Gynaecol. 2009;23:357–368. doi: 10.1016/j.bpobgyn.2008.12.004.
    1. Kamala B.A., Ersdal H.L., Dalen I., Abeid M.S., Ngarina M.M., Perlman J.M., Kidanto H.L. Implementation of a novel continuous fetal Doppler (Moyo) improves quality of intrapartum fetal heart rate monitoring in a resource-limited tertiary hospital in Tanzania: An observational study. PLoS ONE. 2018;13:e0205698. doi: 10.1371/journal.pone.0205698.
    1. Mdoe P.F., Ersdal H.L., Mduma E., Moshiro R., Dalen I., Perlman J.M., Kidanto H. Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting. Int. J. Gynaecol. Obstet. 2018 doi: 10.1002/ijgo.12648.
    1. Hofmeyr G.J., Haws R.A., Bergström S., Lee A.C., Okong P., Darmstadt G.L., Mullany L.C., Oo E.K.S., Lawn J.E., Lawn J.E., et al. Obstetric care in low-resource settings: What, who, and how to overcome challenges to scale up? Int. J. Gynecol. Obstet. 2009;107:S21–S45. doi: 10.1016/j.ijgo.2009.07.017.
    1. Wyatt J. Appropriate medical technology for perinatal care in low-resource countries. Ann. Trop. Paediatr. 2008;28:243–251. doi: 10.1179/146532808X375396.
    1. Mgaya A.H., Massawe S.N., Kidanto H.L., Mgaya H.N. Grand multiparity: Is it still a risk in pregnancy? BMC Pregnancy Childbirth. 2013;13:241. doi: 10.1186/1471-2393-13-241.
    1. Ersdal H.L., Mduma E., Svensen E., Perlman J. Birth asphyxia: A major cause of early neonatal mortality in a Tanzanian rural hospital. Pediatrics. 2012;129:e1238–e1243. doi: 10.1542/peds.2011-3134.
    1. 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;15:302. doi: 10.3390/ijerph15020302.
    1. Mdoe P.F., Ersdal H.L., Mduma E., Moshiro R., Kidanto H., Mbekenga C. Midwives’ perceptions on using a fetoscope and Doppler for fetal heart rate assessments during labor: A qualitative study in rural Tanzania. BMC Pregnancy Childbirth. 2018;18:103. doi: 10.1186/s12884-018-1736-y.
    1. Lie K.K., Grøholt E.-K., Eskild A. Association of cerebral palsy with Apgar score in low and normal birthweight infants: Population based cohort study. BMJ. 2010;341:c4990. doi: 10.1136/bmj.c4990.
    1. Barrera-Gómez J., Basagaña X. Models with Transformed Variables. Epidemiology. 2015;26:e16–e17. doi: 10.1097/EDE.0000000000000247.
    1. Chen H.-Y., Chauhan S.P., Ananth C.V., Vintzileos A.M., Abuhamad A.Z. Electronic fetal heart rate monitoring and its relationship to neonatal and infant mortality in the United States. Am. J. Obstet. Gynecol. 2011;204:491. doi: 10.1016/j.ajog.2011.04.024.
    1. Haws R.A., Yakoob M.Y., Soomro T., Menezes E.V., Darmstadt G.L., Bhutta Z.A. Reducing stillbirths: Screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009;9(Suppl. 1):S5. doi: 10.1186/1471-2393-9-S1-S5.
    1. Devane D., Lalor J.G., Daly S., McGuire W., Cuthbert A., Smith V. Cardiotocography versus intermittent auscultation of fetal heart on admission to labour ward for assessment of fetal wellbeing. Cochrane Database Syst. Rev. 2017 doi: 10.1002/14651858.CD005122.pub5.
    1. American Academy of Pediatrics and American College of Obstetricians and Gynecologists . Guidelines for Perinatal Services. 8th ed. American Academy of Pediatrics; Elk Grove Village, IL, USA: 2013.
    1. Royal College of Obstetrics and Gynaecology . Caesarean section: NICE clinical guideline 132. Royal College of Obstetricians and Gynaecologists; London, UK: 2011.
    1. Litorp H., Kidanto H.L., Nystrom L., Darj E., Essén B. Increasing caesarean section rates among low-risk groups: A panel study classifying deliveries according to Robson at a university hospital in Tanzania. BMC Pregnancy Childbirth. 2013;13:107. doi: 10.1186/1471-2393-13-107.
    1. Martis R., Emilia O., Nurdiati D.S., Brown J. Intermittent auscultation (IA) of fetal heart rate in labour for fetal well-being. Cochrane Database Syst. Rev. 2017;2:CD008680. doi: 10.1002/14651858.CD008680.pub2.
    1. Brocklehurst P., Field D., Greene K., Juszczak E., Keith R., Kenyon S., Linsell L., Mabey C., Newburn M., Plachcinski R., et al. Computerised interpretation of fetal heart rate during labour (INFANT): A randomised controlled trial. Lancet. 2017;389:1719–1729. doi: 10.1016/S0140-6736(17)30568-8.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться