Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 32
- 主要终点
- Rate detection of FGR
研究概览
简要总结
Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and policy makers, and a central question is how to improve the performance of screening during pregnancy in order to provide appropriate care. The recent recommendations and reporting of French results have raised awareness of the need to improve growth screening in France. Based on the existing literature, the hypothesis is that a greater investment in growth monitoring based on a more rigorous interpretation of information available from routinely implemented clinical assessment and ultrasound will allow for significant gains in detection. The current context provides the opportunity to evaluate the application of a training program for serial plotting of Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) on customised charts. This intervention is consistent with French guidelines which support the monthly measurement of SFH, the use of Customised Fetal Weight Reference (CFWR), in particular for referral US (Ultrasound) examinations, and the longitudinal interpretation of growth. These guidelines were recently restated in the clinical practice recommendations issued by the French College of Obstetricians and Gynecologists.
The intervention tested in the trial will include training of professionals for standardization of SFH measurement, introduction of software, and recommendations for growth interpretation and referral examinations. Expected benefits are an increase in antenatal identification of growth restricted fetuses without an increase in the FP rate. Such a program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate antenatal care. This intervention could double the detection rate of SGA births from 20 to 40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be improved.
Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on customised percentile charts supported by provider training, versus standard antenatal care, to improve the detection of FGR. The aim of the investigators is to double rates of antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th percentile for GA.
详细描述
Type of study Randomized cluster trial
Study objectives:
Main objective : To test the effectiveness of the serial plotting of SFH and EFW measures on customised percentile charts supported by provider training, versus standard antenatal care, to improve the detection of FGR. Our aim is to double rates of antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th percentile for GA.
Secondary objectives: To measure the impact of screening program on:
- Perinatal outcomes: stillbirths and neonatal morbidity and mortality including the risk of severe growth restriction (less than the 3rd percentile).
- Rate of false positives and likelihood ratios of screening policies
- Modes of onset of labor and of delivery
- Resource use and costs : the number of antenatal visits and referrals for ultrasound examinations and their indications will be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Mothers will be recruited after delivery if they fulfill the following criteria:
- •Have a singleton pregnancy
- •book before or at 30 weeks GA in the maternity units
- •and deliver in the participating unit
排除标准
- •Terminations of pregnancy
- •Known fibroid uterus or uterine congenital malformations
- •Refusal to participate
- •Minor patient
研究组 & 干预措施
Intervention group
The intervention consists in the standardization of current practices. Clinicians in the intervention maternity units will follow a standardized protocol, and will be asked to measure SFH at each antenatal appointment, collect EFW from the 3rd trimester US, report these values on the chart, and monitor fetal growth according to the protocol guidelines
干预措施: intervention group (Other)
Control group
In the control arm women will benefit from the current routine screening practice for growth failure. The management of pregnancies will remain unchanged. Consultants will be free to monitor growth according to their usual practice. In each maternity unit in the control arm, an information session will be organized on site but its content will be limited to the rational, the objectives of the trial and the study logistics.
结局指标
主要结局
Rate detection of FGR
时间窗: at birth
The primary outcome will be the detection rate of FGR among SGA births, measured in each arm, defined as: * suspected growth restriction mentioned in medical charts * AND at least one referral for additional US for growth monitoring * AND/OR a provider indicated delivery for FGR among the total number of SGA births, defined as infants with a birthweight below the 10th centile of French CFWR.
次要结局
- Number of participants presenting the following perinatal outcomes(at birth)
- Modes of onset of labor and of delivery(at birth)
- Performances of screening policies(at birth)
- Resource use and costs(at birth)