Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting.

Abstract

To compare the frequency of abnormal fetal heart rate (FHR) detection between continuous Doppler and intermittent fetoscope monitoring. A randomized controlled open-label trial was conducted between February 1, 2016, and January 31, 2017, at Haydom Lutheran hospital, Tanzania. Women in active labor with singleton pregnancies and normal FHR at admission were randomly allocated in a 1:1 ratio to receive either continuous or intermittent FHR monitoring. The primary outcome was abnormal FHR detection. 2652 women were enrolled; 1340 received continuous monitoring and 1312 received intermittent monitoring. Continuous FHR monitoring detected abnormal FHR in 108 (8.1%) participants versus 40 (3.0%) participants in the intermittent monitoring group (risk ratio [RR] 2.64, 95% confidence interval [CI] 1.8-3.7; P<0.001). The increased detection rate in the continuous versus intermittent monitoring group was associated with an increase in rate of subsequent intrauterine resuscitations (89 [6.6%] vs 42 [3.2%]; RR 2.07, 95% CI 1.4-2.9; P<0.001). In total, 92 (3.5%) infants had adverse perinatal outcomes, with no significant differences between groups. Continuous FHR monitoring increased identification of abnormal FHR and subsequent intrauterine resuscitations. ClinicalTrials.gov: NCT02790814.