Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial

Paschal Francis Mdoe, Hege L Ersdal, Estomih R Mduma, Jeffrey M Perlman, Robert Moshiro, Peter T Wangwe, Hussein Kidanto, Paschal Francis Mdoe, Hege L Ersdal, Estomih R Mduma, Jeffrey M Perlman, Robert Moshiro, Peter T Wangwe, Hussein Kidanto

Abstract

Background: Neonatal mortality is a global challenge, with an estimated 1.3 million intrapartum stillbirths in 2015. The majority of these were found in low resource settings with limited options to intrapartum fetal heart monitoring devices. This trial compared frequency of abnormal fetal heart rate (FHR) detection and adverse perinatal outcomes (i.e. fresh stillbirths, 24-h neonatal deaths, admission to neonatal care unit) among women intermittently assessed by Doppler or fetoscope in a rural low-resource setting.

Methods: This was an open-label randomized controlled trial conducted at Haydom Lutheran Hospital from March 2013 through August 2015. Inclusion criteria were; women in labor, singleton, cephalic presentation, normal FHR on admission (120-160 beats/minute), and cervical dilatation ≤7 cm. Verbal consent was obtained.

Results: A total of 2684 women were recruited, 1309 in the Doppler and 1375 in the fetoscope arms, respectively. Abnormal FHR was detected in 55 (4.2%) vs 42 (3.1%). (RR = 1.38; 95%CI: 0.93, 2.04) in the Doppler and fetoscope arms, respectively. Bag mask ventilation was performed in 80 (6.1%) vs 82 (6.0%). (RR = 1.03; 95%CI: 0.76, 1.38) of neonates, and adverse perinatal outcome was comparable 32(2.4%) vs 35(2.5%). (RR = 0.9; 95%CI: 0.59, 1.54), in the Doppler and fetoscope arms, respectively.

Conclusion: This trial failed to demonstrate a statistically significant difference in the detection of abnormal FHR between intermittently used Doppler and fetoscope and adverse perinatal outcomes. However, FHR measurements were not performed as often as recommended by international guidelines. Conducting a randomized controlled study in rural settings with limited resources is associated with major challenges.

Trial registration: This clinical trial was registered on April 2013 with registration number NCT01869582 .

Keywords: Doppler; Intermittent fetal heart rate monitoring; Pinard fetoscope.

Conflict of interest statement

Ethics approval and consent to participate

This clinical trial was approved by both the Haydom hospital, Regional Committee for Medical and Health Research Ethics, Western Norway and the Muhimbili University of Health and Allied Sciences ethics and publication committee with clinical trial number NCT01869582. The ethics committee approved the use of verbal consent because the consent were taken from women who were in labor admitted for delivery. The verbal consent was approved aiming at reducing burden to women in labor and for those who were unable to read or write to have equal chance of participating into the study.

Competing interests

All authors declare that they have no competing interest. Although HK is a member of the editorial board of BMC Pregnancy & Childbirth journal, declares no competing interest on the review or publication of this manuscript in this journal.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Consort flow diagram

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