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Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.

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ClinicalTrials.gov Identifier: NCT02862925
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
John E. Fogarty International Center (FIC)
Fulbright
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Fetal Distress Stillbirth Birth Asphyxia Acidosis Procedure: Fetal Scalp Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Pre-Intervention
A consecutive sample of 350 patients will be collected. After informed consent, data will be abstracted from the patient's record including day and time of delivery, method of delivery, parity, gestational age, meconium presence, heart rate abnormality and induction methods. For CD, the following data will be collected: decision-to-delivery time, Partogram adherence, time of each FSST, Apgar score, date and time of delivery and Comorbidities such as: Hypertension-spectrum disorders, Malaria, Postpartum Hemorrhage, Macrosomia, History of CD, Diabetes, Sickle Cell, and HIV status.
Experimental: Post-intervention
The study will take place on the labor ward at KCMC in Moshi, Tanzania. It will involve women who present to the labor ward in labor or who undergo an induction of labor. A consecutive sample of 350 patients will be collected. Study investigators will be present for 24 hours a day, 7 days a week on a rotating schedule during the enrollment period. All patients who fit inclusion and exclusion criteria will be approached if they are deemed medically stable.
Procedure: Fetal Scalp Stimulation
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.




Primary Outcome Measures :
  1. Feasibility as measured by completion of all 3 study objectives [ Time Frame: Day 1 ]
  2. Predicted fetal acidosis from cord blood pH (at thresholds of cord blood pH<7.0, 7.1, and 7.2) [ Time Frame: Day 1 ]
    The primary outcome is the sensitivity and specificity of the Doppler device to predict fetal acidosis based on the fetal scalp stimulation test.


Secondary Outcome Measures :
  1. Fetal distress rate [ Time Frame: Day 1 ]
    The investigators plan to define the fetal distress rate at a large referral center in Tanzania

  2. Change in cesarean delivery rate [ Time Frame: baseline, post introduction of fetal scalp stimulation (during labour) ]
    The investigators plan to compare cesarean delivery rates before and after the introduction of fetal scalp stimulation to fetal monitoring protocols.


Other Outcome Measures:
  1. Birth asphyxia/stillbirth rate [ Time Frame: Day 1 ]
  2. NICU Admission Rate [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862925


Locations
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Tanzania
Kilimanjaro Christian Medical Center
Moshi, Kilimanjaro, Tanzania
Sponsors and Collaborators
Duke University
John E. Fogarty International Center (FIC)
Fulbright
Investigators
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Principal Investigator: John Schmitt, MD Duke UMC, Duke Global Health Institute

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02862925     History of Changes
Other Study ID Numbers: Pro00070952
R25TW009337 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
fetal monitoring
cesarean delivery
obstetrics
midwifery
developing countries
Additional relevant MeSH terms:
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Stillbirth
Asphyxia Neonatorum
Acidosis
Asphyxia
Fetal Distress
Acid-Base Imbalance
Metabolic Diseases
Death
Pathologic Processes
Wounds and Injuries
Fetal Death
Pregnancy Complications
Infant, Newborn, Diseases
Signs and Symptoms