Pregnancy Clinical Trial
Official title:
Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population
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):
1. Improve the identification of risk pregnancies/pathology?
2. Affect the women's well-being?
3. Stimulate maternal-fetal attachment antepartum?
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):
1. Identification of risk pregnancies/pathology?
1. 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).
2. 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.
2. Affect the women's well-being?
1. Primary outcome measure: Maternal concern.
2. Secondary outcome measure: Maternal satisfaction with use of FMC and sense of
control in interpretation of signals from own body and child.
3. Stimulate maternal-fetal attachment antepartum?
1. Primary outcome measure: Maternal-fetal attachment.
2. Secondary outcome measure: Health promoting behavior in pregnancy (smoking habits,
use of alcohol, attending standard program for antenatal care).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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