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

Primary Purpose

Fetal Distress, Stillbirth, Birth Asphyxia

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Fetal Scalp Stimulation
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fetal Distress focused on measuring fetal monitoring, cesarean delivery, obstetrics, midwifery, developing countries

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kilimanjaro Christian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-Intervention

Post-intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility as measured by completion of all 3 study objectives
Predicted fetal acidosis from cord blood pH (at thresholds of cord blood pH<7.0, 7.1, and 7.2)
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

Fetal distress rate
The investigators plan to define the fetal distress rate at a large referral center in Tanzania
Change in cesarean delivery rate
The investigators plan to compare cesarean delivery rates before and after the introduction of fetal scalp stimulation to fetal monitoring protocols.

Full Information

First Posted
August 2, 2016
Last Updated
September 1, 2017
Sponsor
Duke University
Collaborators
Fogarty International Center of the National Institute of Health, Fulbright
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1. Study Identification

Unique Protocol Identification Number
NCT02862925
Brief Title
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
Official Title
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Fogarty International Center of the National Institute of Health, Fulbright

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Distress, Stillbirth, Birth Asphyxia, Acidosis
Keywords
fetal monitoring, cesarean delivery, obstetrics, midwifery, developing countries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-Intervention
Arm Type
No Intervention
Arm Description
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.
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fetal Scalp Stimulation
Intervention Description
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 Measure Information:
Title
Feasibility as measured by completion of all 3 study objectives
Time Frame
Day 1
Title
Predicted fetal acidosis from cord blood pH (at thresholds of cord blood pH<7.0, 7.1, and 7.2)
Description
The primary outcome is the sensitivity and specificity of the Doppler device to predict fetal acidosis based on the fetal scalp stimulation test.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Fetal distress rate
Description
The investigators plan to define the fetal distress rate at a large referral center in Tanzania
Time Frame
Day 1
Title
Change in cesarean delivery rate
Description
The investigators plan to compare cesarean delivery rates before and after the introduction of fetal scalp stimulation to fetal monitoring protocols.
Time Frame
baseline, post introduction of fetal scalp stimulation (during labour)
Other Pre-specified Outcome Measures:
Title
Birth asphyxia/stillbirth rate
Time Frame
Day 1
Title
NICU Admission Rate
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Schmitt, MD
Organizational Affiliation
Duke UMC, Duke Global Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kilimanjaro Christian Medical Center
City
Moshi
State/Province
Kilimanjaro
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26433402
Citation
Visser GH, Ayres-de-Campos D; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Adjunctive technologies. Int J Gynaecol Obstet. 2015 Oct;131(1):25-9. doi: 10.1016/j.ijgo.2015.06.021. No abstract available.
Results Reference
background
PubMed Identifier
24669324
Citation
Omo-Aghoja L. Maternal and fetal Acid-base chemistry: a major determinant of perinatal outcome. Ann Med Health Sci Res. 2014 Jan;4(1):8-17. doi: 10.4103/2141-9248.126602.
Results Reference
background
PubMed Identifier
6695974
Citation
Clark SL, Gimovsky ML, Miller FC. The scalp stimulation test: a clinical alternative to fetal scalp blood sampling. Am J Obstet Gynecol. 1984 Feb 1;148(3):274-7. doi: 10.1016/s0002-9378(84)80067-8.
Results Reference
background
PubMed Identifier
7137256
Citation
Clark SL, Gimovsky ML, Miller FC. Fetal heart rate response to scalp blood sampling. Am J Obstet Gynecol. 1982 Nov 15;144(6):706-8. doi: 10.1016/0002-9378(82)90441-0.
Results Reference
background
PubMed Identifier
11777523
Citation
Skupski DW, Rosenberg CR, Eglinton GS. Intrapartum fetal stimulation tests: a meta-analysis. Obstet Gynecol. 2002 Jan;99(1):129-34. doi: 10.1016/s0029-7844(01)01645-3.
Results Reference
background
PubMed Identifier
21410829
Citation
Rathore AM, Ramji S, Devi CB, Saini S, Manaktala U, Batra S. Fetal scalp stimulation test: an adjunct to intermittent auscultation in non-reassuring fetal status during labor. J Obstet Gynaecol Res. 2011 Jul;37(7):819-24. doi: 10.1111/j.1447-0756.2010.01442.x. Epub 2011 Mar 16.
Results Reference
background
PubMed Identifier
30760224
Citation
Goodman DM, Mlay P, Thielman N, Small MJ, Schmitt JW. Using fetal scalp stimulation with Doppler ultrasonography to enhance intermittent auscultation in low-resource settings: a diagnostic trial from Tanzania. BMC Pregnancy Childbirth. 2019 Feb 13;19(1):71. doi: 10.1186/s12884-019-2212-z.
Results Reference
derived
Links:
URL
https://sustainabledevelopment.un.org/topics
Description
Sustainable Development Goals & Topics .:. Sustainable Development Knowledge Platform

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

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