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

NCT02862925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2017-09-05

No results posted yet for this study

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.

Conditions

  • Fetal Distress
  • Stillbirth
  • Birth Asphyxia
  • Acidosis

Interventions

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.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Fulbright

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • John Schmitt, MD · Duke UMC, Duke Global Health Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Tanzania

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02862925 on ClinicalTrials.gov