BackgroundNeonatal 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.MethodsThis 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.ResultsA 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.ConclusionThis 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 registrationThis clinical trial was registered on April 2013 with registration number NCT01869582.

Birth asphyxia (BA), assumed to be related to intrapartum related hypoxia-ischemia, accounts for one million neonatal deaths annually. In the low resource setting BA is usually defined as a failure to initiate or sustain spontaneous breathing at birth. In the resource replete setting BA is a biochemical definition related to impaired gas exchange, due to interruption of placental blood flow (PBF). An umbilical arterial pH <7.00 referred to as severe fetal acidemia, reflects a degree of acidosis, where potential risk of adverse neurologic sequelae is increased. However, even with this degree of acidemia, the likelihood of mortality or adverse neurologic sequelae remains low. The aim is to focus on the definition of BA in the low resource setting, and compare it to the diagnosis in the resource replete setting, highlighting the importance of interruption of placental blood flow as it relates to morbidity and mortality. With asphyxia, the fetus aims to redistribute cardiac output to protect more vital organs e.g., brain, myocardium, and adrenal gland at the expense of decreased flow to organs such as kidney or intestine. In an experimental newborn model, animals subjected to asphyxia immediately develop primary apnea with bradycardia sustained blood pressure and normal pH. Recovery of respirations follows basic interventions, i.e. stimulation coupled with reversal of asphyxia. However, if asphyxia is sustained, secondary apnea manifests with bradycardia, hypotension, and pH <7.00. More intensive resuscitation including bag mask ventilation ± intubation ± cardio-pulmonary resuscitation may be necessary for correction upon reversal of asphyxia. Identification of a severely acidemic state (cord arterial pH < 7.00) in the newborn, may help to differentiate the truly asphyxiated intrapartum related cases that result in mortality, from those cases where mortality is related to delay in or ineffective basic resuscitation.

Continuous FHR monitoring increased identification of abnormal FHR and subsequent intrauterine resuscitations. ClinicalTrials.gov: NCT02790814.