Evaluation of Fetal Response to Intrapartum Digital Fetal Scalp Stimulation Upon Detection of Suspected Loss of Fetal Well-being in Suspicious and Pathologic Cardiotocographic Recordings, to Identify Intrapartum Fetal Hypoxia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Percentage of fetuses with positive response to digital fetal scalp stimulation, intrapartum ph greater than 7.20, newborn ph greater than 7.20 and good neonatal outcomes
研究概览
简要总结
The main objective of this study is to evaluate whether digital fetal scalp stimulation improves fetal well-being in fetuses with suspicious or pathological cardiotocographic recordings, showing an improvement in cardiotocographic recording patterns and normal values in intrapartum fetal scalp blood results.
Upon detection of a suspicious or pathologic cardiotocographic recording, the investigators need to perform an objective verification of fetal well-being.
Currently, fetal scalp blood is the reference test to assess intrapartum fetal hypoxia, according to the protocols of the Spanish Society of Gynecology and Obstetrics.
This procedure lasts about 5 minutes and consists of taking a small sample of the fetal scalp, through a vaginal exploration, the blood is collected in a thin tube and analyzed by a machine in the delivery room obtaining the results in a few minutes.
The investigators emphasize that this test is not part of the study, as long as the monitor is suspicious or pathological, it will be performed according to protocol to objectively assess fetal well-being.
Currently there are studies that support the use of fetal scalp stimulation as an alternative technique to assess intrapartum fetal well-being and predict neonatal outcomes, but they also highlight its limited evidence.
Digital fetal scalp stimulation is a NON-invasive method, as no instrument is required and fetal stimulation is a 30-60 second surface rubbing pressure, which is performed manually, through vaginal exploration, the same technique the investigators use to assess dilation during the labor process.
Each patient will be randomly assigned to a study group:
Experimental group: before the extraction of capillary blood from the fetal scalp, fetal head stimulation will be performed, a technique that poses no risk to the baby. The researchers need the consent of the participants to perform this technique and collect data.
Control group: fetal head stimulation will not be applied, but data from the clinical history necessary for this study will be collected.
In no case will extraordinary or unnecessary tests be performed for participation in this study.
This study will have an Informed Consent document.
This study will be carried out at the Fundación Jiménez Díaz and Zarzuela and will include 182 patients for 24 months.
详细描述
The goal of intrapartum care is to ensure excellent maternal and perinatal outcomes. Normal labor is characterized by regular uterine contractions, which cause repeated transient interruptions in fetal oxygenation. Most fetuses tolerate this process well, but some do not. The fetal heart rate (FHR) pattern helps distinguish the former from the latter, as it is an indirect marker of fetal cardiac and central nervous system responses to changes in blood pressure, blood gases, and acid-base status. The term "suspected fetal compromise or risk of loss of fetal well-being" is used in obstetrics, when the fetus is considered to be at increased risk of ischemic hypoxic injury, brain damage or death, and is one of the most common indications for emergency cesarean section during labor. In our setting, continuous electronic fetal heart rate monitoring recorded by cardiotocography (CTG) is routinely used in labor to identify fetuses that may be at increased risk of compromise and may benefit from further evaluation of fetal well-being or other interventions. CTG tracings display the fetal heart rate (FHR) pattern along with maternal uterine activity.
CTG patterns are classified into discrete general categories according to four criteria: basal FHR, heart rate variability, presence or absence of FHR accelerations, and decelerations. An example of such a classification system is the 2015 FIGO International Federation of Gynecology and Obstetrics guideline, on which the investigators will base our study. The Spanish Society of Gynecology and Obstetrics defines the registry in normal, suspicious, and pathologic categories. Regardless of the classification system used, abnormal FHR patterns that do not respond to basic intrauterine resuscitation measures require further evaluation of fetal well-being and/or termination of pregnancy, either by cesarean section, assisted vaginal delivery, or spontaneous vaginal delivery.
CTG has a high false-positive rate for fetal compromise (60%) and the studies of Chandraharan et al are gaining momentum, where intrapartum interventions should be based on a thorough understanding of the features observed on the tracing recordings to differentiate normal fetal response to continued stress from the onset of compensation, so that timely action can be taken to avoid hypoxic ischemic encephalopathy and prenatal deaths, while avoiding unnecessary intrapartum interventions to the mother. Cesarean section rates are increasing worldwide, much of that increase is due to primary cesarean sections among nulliparous women due to emergency procedures in labor. Our great challenge is to achieve a reliable test of fetal well-being during labor and to be able to be minimally invasive for both mother and fetus.
When a suspicious or pathologic FHR pattern is detected and immediate delivery is not warranted, further evaluation of fetal well-being is necessary; such second-line evaluations or tests include fetal scalp blood, in Spain Gold standard to identify fetuses with acidosis and reduce the false positive rate of CTG, and digital fetal scalp stimulation. Clinical guidelines support the use of digital fetal scalp stimulation but also note that research evidence is limited. Digital fetal scalp stimulation is the least invasive method, as it does not require instruments; it involves rubbing the surface of the fetal scalp with pressure for 30 to 60 seconds; the response to stimulation should be evident in cardiotocographic patterns over the next 10 minutes, using a 5-minute average. Fetal scalp stimulation should elicit an acceleration of FHR defined as an increase in FHR ≥ 15 bpm for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of an acceleration of FHR or an increase in variability (when previously reduced), or both, is interpreted as a positive response, comparable to a normal fetal scalp blood pH result greater than 7.20.
Fetal scalp blood sampling is an intrapartum procedure to assess the presence and degree of fetal acidemia by analyzing fetal capillary blood for pH or lactate, as both give similar results, with pH being the gold standard test for fetal acidosis in our setting. An amnioscope with a light source is used to expose the fetal scalp, which is cleaned with a 2% aqueous chlorhexidine gauze from blood, mucosa and amniotic fluid, then the scalp is punctured with a 2 mm blade. The blood is collected in long capillary tubes. The test requires the cervix to be dilated at least 2 to 3 cm, can be difficult to perform and may be uncomfortable for the laboring woman. It is contraindicated when the mother is known to have a serious transmissible infection, such as HIV or hepatitis, and in fetuses at increased risk of hemorrhage. Rare complications described in case reports include infection, hemorrhage and cerebrospinal fluid leakage. The procedure will result in stimulation of the fetus, but the primary intent is to collect a scalp blood that will allow quantitative analysis of fetal pH or lactate, reflecting fetal blood oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with singleton pregnancy.
- •Cephalic presentation.
- •Gestational age greater than or equal to 37 weeks.
- •Pathological cardiotocographic record according to the criteria published by FIGO and with indication to perform a second-line complementary test, in our case a gold standard test of fetal scalp blood FBS, which confirms or not if there is a risk of loss of fetal well-being and the need for fetal extraction.
- •Signature of HIP and CI for data collection.
排除标准
- •Under 18 years of age.
- •Contraindication for FBS
- •Uterine dilatation that does not make FBS possible.
- •Fetuses at increased risk of hemorrhage.
研究组 & 干预措施
digital fetal scalp stimulation dFSS
Digital fetal scalp stimulation will be performed for a period of 30 seconds prior to obtaining the fetal blood sample. Digital fetal scalp stimulation will be performed by vaginal touch with a gauze pad and applying rubbing pressure over the fetal scalp for 30 to 60 seconds. This procedure will be recorded on the same RCTG. The FHR pattern on the cardiotocographic recording is closely monitored for 1 to 10 minutes, using a 5-minute mean, following fetal stimulation the fetus should respond with an acceleration of FHR defined as an increase in FHR ≥ 15 bpm (beats per minute for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of an acceleration of FHR or an increase in variability when it was previously reduced, or both, is interpreted as a positive response, comparable to a normal fetal blood scalp sample FBS result.
干预措施: Digital fetal scalp stimulation dFSS (Diagnostic Test)
NO digital fetal scalp stimulation dFSS
The fetal blood sampling will be performed, since in our environment it is the gold standard method included in the SEGO recommendations.
There is NO intervention.
结局指标
主要结局
Percentage of fetuses with positive response to digital fetal scalp stimulation, intrapartum ph greater than 7.20, newborn ph greater than 7.20 and good neonatal outcomes
时间窗: 2 years
To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation, obtain an intrapartum pH greater than 7.20, at birth a pH greater than 7.20, and good neonatal outcomes.
次要结局
- Differences in newborn seizure percentages in fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and neonatal pH above 7.20.(2 years)
- Differences in the cardiotocographic pattern of fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation(2 years)
- Differences in the results of intrapartum fetal scalp blood of fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation(2 years)
- Differences in newborn ph results of fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation(2 years)
- Differences in the first minute apgar scores of the newborns in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation(2 years)
- Differences in apgar scores at 5 minutes of life of newborns in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation(2 years)
- Differences in the results of the type of newborn resuscitation in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation(2 years)
- Differences in neonatal unit admission rates in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation(2 years)
- Differences in the percentages of newborn deaths in fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation(2 years)
- Differences in completion of cesarean delivery in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.(2 years)
- Differences in instrumental deliveries in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.(2 years)
- Differences in vaginal deliveries in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and intrapartum pH greater than 7.20(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and intrapartum pH less than or equal to 7.20(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and intrapartum pH above 7.20.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and intrapartum pH less than or equal to 7.20.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and neonatal pH above 7.20.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and neonatal pH less than or equal to 7.20.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and neonatal pH less than or equal to 7.20.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and apgar score greater than or equal to 8 in the first minute of life.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score greater than or equal to 8 in the first minute of life.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and apgar score less than 8 in the first minute of life.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score less than 8 in the first minute of life.(2 years)
- Percentage of fetuses with a positive response to digital fetal scalp stimulation and an Apgar score greater than or equal to 8 at five minutes of life.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score greater than or equal to 8 at five minute of life.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and apgar score less than 8 at five minute of life.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score less than 8 at five minute of life.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and type of neonatal resuscitation.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and type of neonatal resuscitation.(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and requiring admission to the neonatal unit.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and requiring admission to the neonatal unit.(2 years)
- Percentage of fetuses with a positive response to digital fetal scalp stimulation who seizure(2 years)
- Percentage of fetuses with a negative response to digital fetal scalp stimulation who seizure(2 years)
- Percentage of fetuses with positive response to digital fetal scalp stimulation and neonatal death.(2 years)
- Percentage of fetuses with negative response to digital fetal scalp stimulation and neonatal death.(2 years)
研究者
Raquel Maqueda Moreno
Investigator name
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz