Interest of the Kleihauer in Patients With Decreased Active Fetal Movements
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,683
- 试验地点
- 1
- 主要终点
- To evaluate the diagnostic performance of each of the two tests: Kleihauer test / Doppler + fetal heart rate for the diagnosis of neonatal anemia (by cord blood sampling) among patients presenting with decreased active fetal movements.
研究概览
简要总结
Fetomaternal hemorrhage is the passage of fetal red blood cells through the placental barrier into the maternal blood. This phenomenon frequently occurs in the third trimester for small quantities of blood < 0.5 ml and is without fetal consequences in rhesus positive patients.
This hemorrhage can sometimes be more important and be the cause of fetal anemia or even fetal death in utero.
Diagnostic confirmation is biological and is performed using the Kleihauer test. It is based on the identification by the biologist of fetal cells circulating in the maternal blood by counting acid-fast fetal cells under the microscope. It is therefore a time-consuming examination with significant inter- and intra-observer variability.
The clinical sign most often reported in the literature, and the earliest sign that may suggest fetomaternal hemorrhage complicated by fetal anemia, is a decrease in active fetal movements. However, this is an aspecific sign and is one of the most common reasons for consultation in obstetric emergencies.
详细描述
There are other arguments in favor of complicated fetomaternal hemorrhage: The fetal heart rate is often altered in severe fetal anemia, with sinusoidal rhythm being pathognomonic but uncommon. A slightly oscillating rhythm or variable decelerations are also found.
On ultrasound, peak systolic middle cerebral artery velocity > 1.5 MoM correlates with fetal anemia early before the appearance of hydrops.
Some studies show that peak systolic middle cerebral artery velocity correlates better with neonatal hemoglobin than the Kleihauer test, for which no threshold has been found to predict an unfavorable outcome. Thus, even if the Kleihauer test is positive, the positive predictive value for fetal anemia is low. The detection of a small amount of fetomaternal hemorrhage by Kleihauer in the absence of evidence of anemia could even be deleterious, potentially leading to an excess of additional investigations and obstetrical interventions.
The interest of systematically performing the Kleihauer test to search for fetomaternal hemorrhage is uncertain at this time because of the development and the undeniable contribution of ultrasound. However, in France, it is still carried out in most maternity wards in the absence of recommendations for any decrease in active fetal movements.
Only one article has looked specifically at fetomaternal hemorrhage in a group of patients consulting for a decrease in active fetal movements, calling into question its interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients whose age ≥ 18 years
- •French speaking patients
- •Consultation for decreased active fetal movements
- •Singleton pregnancies
- •Gestational age between 24 weeks of amenorrhea and 41 weeks of amenorrhea +5 days
排除标准
- •Patients under guardianship or curatorship
- •Patients deprived of liberty
- •Patients under court protection
- •Patients who object to the use of their data for this research
- •Fetal or neonatal anemia of documented cause other than fetomaternal hemorrhage
- •Consultation for metrorrhagia
- •Consultation for Abdominal Trauma
- •Consultation for external maneuver version
结局指标
主要结局
To evaluate the diagnostic performance of each of the two tests: Kleihauer test / Doppler + fetal heart rate for the diagnosis of neonatal anemia (by cord blood sampling) among patients presenting with decreased active fetal movements.
时间窗: Day 1
Statistical performance of tests (sensitivity, specificity, negative/positive predictive value and positive/negative likelihood ratio)
次要结局
- To evaluate the diagnostic performance of the middle cerebral artery Doppler + fetal heart rate pair in comparison with the Kleihauer test for the diagnosis of neonatal anemia.(Day 1)
- To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.(Day 1)