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

September 1, 2017 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Kilimanjaro
      • Moshi, Kilimanjaro, Tanzania
        • Kilimanjaro Christian Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by completion of all 3 study objectives
Time Frame: Day 1
Day 1
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal distress rate
Time Frame: Day 1
The investigators plan to define the fetal distress rate at a large referral center in Tanzania
Day 1
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.
baseline, post introduction of fetal scalp stimulation (during labour)

Other Outcome Measures

Outcome Measure
Time Frame
Birth asphyxia/stillbirth rate
Time Frame: Day 1
Day 1
NICU Admission Rate
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Fogarty International Center of the National Institute of Health
Fulbright

Investigators

  • Principal Investigator: John Schmitt, MD, Duke UMC, Duke Global Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00070952
  • R25TW009337 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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