Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian
 Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the
 intermittent auscultation protocols at KCMC, and to validate whether or not a handheld
 Doppler device can perform the fetal scalp stimulation test accurately.
Background:

 Each year an estimated 2.6 million stillbirths occur globally. Nearly half, 1.2 million, of
 these occur intrapartum and an additional 650,000 children are born alive but die soon after
 birth due to birth asphyxia which is caused by hypoxia during labor. The vast majority of
 these deaths occur in low- and middle-income countries (LMICs). In high-income countries,
 obstetric providers utilize electronic fetal monitoring (EFM) to monitor fetuses during
 labor, but controversy surrounds implementing this technology in LMICs. What observing EFM
 patterns has taught us is that fetuses that respond to scalp stimulation with a rise in their
 heart rate are essentially guaranteed to be well oxygenated. This physiologic phenomenon,
 known as the fetal scalp stimulation test (FSST), has potential to improve fetal monitoring
 in LMICs, but it has never been studied using Doppler technology. This study aims to collect
 information about the prevalence of fetal distress in an obstetric referral hospital, to test
 the sensitivity and specificity of FSST with a Doppler device, and to collect pilot data
 using FSST as an adjunct to improve fetal monitoring. The outcome of the study would be to
 identify a trend in cesarean delivery rate reduction, intrapartum stillbirth, and birth
 asphyxia.

 The vast majority of acute intrapartum-related morbidity and mortality occurs in low- and
 middle-income countries (LMIC) where the care of mothers and fetuses during labor remains
 under studied as is our understanding of how to implement and evaluate programs that address
 the delivery of quality care. Providing safe and effective obstetric care requires the
 development of processes that are appropriate for each clinical setting considering
 resources, burden of disease, and cultural factors as well as implementing those processes in
 an effective way so that they become standard practice over time. Internationally midwives
 employ intermittent auscultation (IA) to monitor fetuses with Pinard stethoscopes or Doppler
 devices. In high-resource settings providers rely on computerized electronic fetal monitoring
 (EFM) to identify signs of fetal acidosis, although this has not been shown superior to IA.
 Recently, the Federation International of Gynecology and Obstetrics published recommendations
 for adjunctive tests to fetal monitoring, but the recommendations were limited to the
 high-resource EFM paradigm. On this subject, an expert on fetal physiology from Nigeria
 stated, "it is imperative that appropriate diagnostic and management modalities for fetal
 hypoxia be available and accessible. This is the only way the burden of perinatal morbidity
 and mortality can be reduced." Currently, fetal scalp stimulation (FSST) is the only
 low-cost, validated, adjunctive test that could be used to this end in the majority world,
 but it has not been studied for this purpose.

 STATEMENT OF THE PROBLEM Tanzania ranks as the 9th worst country for stillbirth globally
 experiencing 47,100 losses in 2015. Fetal monitoring at Kilimanjaro Christian Medical Center
 (KCMC) in Moshi, Tanzania, and countless labor wards around the world, is limited by the
 inability to accurately identify fetal acidosis in laboring patients. Misdiagnosis leads
 either to excess cesarean delivery (CD) or excess asphyxiated births. The study hypothesis is
 that implementing fetal scalp stimulation test (FSST) into labor protocols will reduce CD
 rates and improve neonatal outcomes leading to a reduction in maternal and neonatal
 mortality. Proving this will require a large randomized-controlled trial (RCT). The necessary
 first step is a proof-of-concept, feasibility study that will provide pilot data and inform
 future efforts.
Inclusion Criteria:

 -  Gestational Age ≥ 37 weeks

 -  Singleton gestation

 -  Cephalic presentation

 -  First stage of labor

 -  Fetal distress diagnosed in the labor ward by either FHR >160 or <110, and/or grade
 2-3 meconium-stained liquor

 Exclusion Criteria:

 -  Chorioamnionitis

 -  Known fetal anomaly

 -  Antepartum hemorrhage

 -  Eclampsia

 -  Other maternal/fetal factors precluding vaginal delivery