Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
Condition: Fetal Distress; Stillbirth; Birth Asphyxia; Acidosis
MeSH terms: Stillbirth; Asphyxia Neonatorum; Acidosis; Asphyxia; Fetal Distress
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fetal Scalp Stimulation
Intervention type(s): Procedure
Intervention description(s): During a routine vaginal exam, if there is concern for fetal distress based on local definitions, the midwife will gently stroke the fetal head with her finger. She will then observe for a rise in the fetal heart rate as observed by the Doppler monitor. A rise to above 15 beats per minute above the baseline is termed an "acceleration" and NEGATIVE test. Absence of an acceleration is a POSITIVE test and reason for intervention.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: fetal monitoring; cesarean delivery; obstetrics; midwifery; developing countries