Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)
研究概览
简要总结
The aim is to test effects of using formal kick counting chart in the third trimester of pregnancy in an unselected population. The research questions are:
Does Fetal Movement Counting (FMC):
- Improve the identification of risk pregnancies/pathology?
- Affect the women's well-being?
- Stimulate maternal-fetal attachment antepartum?
详细描述
Fetal activity serves as an indirect measure of central nervous system integrity and function, and regular FM can be regarded as an expression of fetal well-being.A hypoxic fetus responds automatically by redistributing blood away from the non-essential organs which lead to a reduction of non-vital activities; movements. Conversely, pregnancies in which the mother report decreased fetal movements (DFM) is associated with adverse outcomes and may indicate danger for the fetus. In cases were DFM are associated with complications of pregnancy, maternal lack of sensitivity and awareness to fetal movements may be a risk factor for her pregnancy. The most important current identifier of DFM is the women's perception of what is a decrease of FM. Fetal movement counting may be a tool for the mothers that might increase identification of risk pregnancies.
The outcome measures are (referring to the research questions above):
-
Identification of risk pregnancies/pathology?
-
Primary outcome measures: Numbers of identified pathological conditions in pregnancies (fetal growth restriction (FGR), acute caesarean section on fetal indication/non-reactive non-stress test (NST), oligohydramnios, pathologic blood flow in arteria umbilicalis, maternal perception of absent fetal movements for more than 24 hours before admission to hospital, or perinatal death).
-
Secondary outcome measures: Frequency of consultations because of maternal concern, use of resources in evaluation of these pregnancies (NST, ultrasound, Doppler, recurrent consultations), induced or spontaneous start of delivery, mode of birth.
-
Affect the women's well-being?
-
Primary outcome measure: Maternal concern.
-
Secondary outcome measure: Maternal satisfaction with use of FMC and sense of control in interpretation of signals from own body and child.
-
Stimulate maternal-fetal attachment antepartum?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women booking at screening ultrasound in pregnancy week 17-20
- •native speaking women
- •singleton pregnancies
排除标准
- •women with pregnancies with severe anomalies or other cause to consider termination
研究组 & 干预措施
A
These women will follow standard antenatal care according to the Norwegian Guidelines
B
Intervention group for Fetal Movement Counting
干预措施: Fetal Movement Counting (Other)
结局指标
主要结局
Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)
时间窗: One and a half year
次要结局
- Frequency of consultations, use of resources and mode of birth, maternal satisfaction and sense of control in interpretation of signals from own body and child, health promoting behavior(One and a half year)
研究者
Frederik Froen
Head of Department
Norwegian Institute of Public Health