Evidence map›Paper›PMID 30760224›Full record

Trial reportBMC pregnancy and childbirth2019

Using fetal scalp stimulation with Doppler ultrasonography to enhance intermittent auscultation in low-resource settings: a diagnostic trial from Tanzania.

David M Goodman, Pendo Mlay, Nathan Thielman, Maria J Small, John W Schmitt

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02862925 (Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02862925 nacompletednot on this map

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

TypeinterventionalSponsorDuke UniversityRan2016 to 2017Enrolled550ConditionsFetal Distress, Stillbirth, Birth Asphyxia, AcidosisArmsFetal Scalp Stimulation
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

David M GoodmanHubert-Yeargan Center for Global Health, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA. david.goodman@orlandohealth.com.
Pendo MlayKilimanjaro Christian Medical Centre, Department of Obstetrics and Gynecology, Kilimanjaro Christian Medical University College, Moshi, Tanzania.
Nathan ThielmanHubert-Yeargan Center for Global Health, Department of Internal Medicine: Infectious Diseases, Duke University Medical Center, Durham, NC, USA.
Maria J SmallHubert-Yeargan Center for Global Health, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
John W SchmittHubert-Yeargan Center for Global Health, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
Duke Medical Center · USCenter for Global Health · USDuke University · USKilimanjaro Christian Medical Centre · TZ

Funding

Vanderbilt-Emory-Cornell-Duke Consortium for Global Health Fellows (VECDor)R25TW009337 · FIC · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HEIMBURGER, DOUGLAS CORBETT, VERMUND, STEN H. · 2012 to 2016
$6.3M
FIC NIH HHS R25 TW009337Fogarty International Center R25TW009337
6 · The paper itself

Abstract

backgroundHypoxia during labor contributes to 2.2 million intrapartum and early neonatal deaths each year. An additional 0.6-1.0 million cases of life-long disability occur because of fetal hypoxia during labor. It is known that fetal heart rate changes in labor correspond to hypoxia and neurologic compromise, but a reliable, low-cost method for detecting these changes is not available. In this study we sought to compare the ability of a handheld Doppler device to detect accelerations as part of the fetal scalp stimulation test and to compare the diagnostic performance of routine intermittent auscultation with auscultation that is augmented with fetal scalp stimulation.

methodsThis non-randomized, pre- and post-diagnostic trial was conducted with 568 maternal-fetus pairs at Kilimanjaro Christian Medical Center in Moshi, Tanzania. The first objective was to determine whether a handheld Doppler device could detect fetal accelerations in labor with reasonable accuracy as compared with a cardiotocography machine. We performed the fetal scalp stimulation test on 50 fetuses during labor using both a handheld Doppler and a cardiotocography machine and compared the outcomes for correlation using the kappa correlation coefficient. During the second objective, two groups of laboring women were monitored either with intermittent auscultation alone per routine protocol (N = 251) or with intermittent auscultation augmented with fetal scalp stimulation per study protocol(N = 267). Diagnostic accuracy of the monitoring method was determined by comparing umbilical cord blood gases immediately after birth with the predicted state of the baby based on monitoring. The analyses included sensitivity, specificity, and positive and negative predictive values.

resultsThe prevalence of fetal acidemia ranged from 15 to 20%. Adding the fetal scalp stimulation test to intermittent auscultation protocols improved the performance of intermittent auscultation for detecting severe acidemia (pH < 7.0) from 27 to 70% (p = 0.032). The negative predictive value of intermittent auscultation augmented with the fetal scalp stimulation test ranged from 88 to 99% for mild (pH < 7.2) to severe fetal acidemia.

conclusionsThe fetal scalp stimulation test, conducted with a handheld Doppler, is feasible and accurate in a limited resource setting. It is a low-cost solution that merits further evaluation to reduce intrapartum stillbirth and neonatal death in low-income countries.

trial registrationClinicalTrials.gov ( NCT02862925 ).

Indexed as

Echocardiography, DopplerFemaleFetal HypoxiaFetal MonitoringHeart AuscultationHeart Rate, FetalHumansLabor, ObstetricPregnancyScalpTanzaniaUltrasonography, DopplerAcidemiaCardiotocographyCesarean deliveryDopplerFetal monitoringFetal scalp stimulationIntermittent auscultationNeonatal mortalitySub-Saharan AfricaTanzaniaValidation

Identifiers

PMID30760224
PMCPMC6374908
OpenAlexW2924430883

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.