Fetal DistressNCT02862925
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
A study testing Fetal Scalp Stimulation in people with Fetal Distress and Stillbirth, run by Duke University at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Fetal Distress, Stillbirth, Birth Asphyxia
- What is being tested?
- Fetal Scalp Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Oct 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Chorioamnionitis
- Known fetal anomaly
- Antepartum hemorrhage
- Eclampsia
- Other maternal/fetal factors precluding vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fetal Distress, Stillbirth, Birth Asphyxia, Acidosis
- Being tested
- Fetal Scalp Stimulation
- Keywords
- fetal monitoring, cesarean delivery, obstetrics, midwifery, developing countries
- Medical subject headings
- Fetal Distress, Stillbirth, Asphyxia Neonatorum, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Scalp StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No 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. |
| Post-intervention | Experimental | 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. Receives: Procedure: Fetal Scalp Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by completion of all 3 study objectives
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (2)
Fetal distress rate
The investigators plan to define the fetal distress rate at a large referral center in Tanzania
Measured: Day 1
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.
Measured: baseline, post introduction of fetal scalp stimulation (during labour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Fulbright
- Responsible party
- Sponsor
- Investigators
- John Schmitt, MD, Principal investigator, Duke UMC, Duke Global Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862925
- Sponsor's protocol ID
- Pro00070952
- Other IDs
- R25TW009337
- Status last verified
- Apr 2017
- First submitted
- 2 Aug 2016
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26433402Omo-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.
PubMed 24669324Clark 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.
PubMed 6695974Clark 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.
PubMed 7137256Skupski 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.
PubMed 11777523Rathore 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.
PubMed 21410829Goodman 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.
PubMed 30760224
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
- ClinicalTrials.gov ID
- NCT02862925
- Acronym / sponsor ID
- Pro00070952
- Conditions
- Fetal Distress, Stillbirth, Birth Asphyxia, Acidosis
- Keywords
- fetal monitoring, cesarean delivery, obstetrics, midwifery, developing countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Fulbright
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No 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. |
| Post-intervention | Experimental | Procedure: Fetal Scalp StimulationThe 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Chorioamnionitis
- Known fetal anomaly
- Antepartum hemorrhage
- Eclampsia
- Other maternal/fetal factors precluding vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Scalp StimulationDuring 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. | Procedure or surgery | Post-intervention |
Primary outcome
Feasibility as measured by completion of all 3 study objectives
Time frame: 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.
2 secondary outcomes
Fetal distress rate
Time frame: Day 1
Change in cesarean delivery rate
Time frame: baseline, post introduction of fetal scalp stimulation (during labour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Background: PubMed 26433402Visser 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.
- Background: PubMed 24669324Omo-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.
- Background: PubMed 6695974Clark 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.
- Background: PubMed 7137256Clark 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.
- Background: PubMed 11777523Skupski 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.
- Background: PubMed 21410829Rathore 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.
- Derived from this study: PubMed 30760224Goodman 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.
- Sustainable Development Goals \& Topics .:. Sustainable Development Knowledge PlatformLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Schmitt, MD principal investigator
Duke UMC, Duke Global Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Scalp Stimulation in people with Fetal Distress and Stillbirth, run by Duke University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by completion of all 3 study objectives (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862925, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.