Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02862925|
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : September 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fetal Distress Stillbirth Birth Asphyxia Acidosis||Procedure: Fetal Scalp Stimulation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
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.
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.
- 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.
- Fetal distress rate [ Time Frame: Day 1 ]The investigators plan to define the fetal distress rate at a large referral center in Tanzania
- 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.
- Birth asphyxia/stillbirth rate [ Time Frame: Day 1 ]
- NICU Admission Rate [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862925
|Kilimanjaro Christian Medical Center|
|Moshi, Kilimanjaro, Tanzania|
|Principal Investigator:||John Schmitt, MD||Duke UMC, Duke Global Health Institute|