Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05503433 |
Other study ID # |
FKH Parameters |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 1, 2022 |
Est. completion date |
December 1, 2022 |
Study information
Verified date |
August 2022 |
Source |
Halic University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Objective: This study was designed to determine whether maternal cortisol levels affect fetal
heart rate (FHR) patterns at third trimester.
Design: Cross-sectional descriptive study. Setting: Prenatal wards of 1 public maternity
services in Istanbul, Turkey. Participants: This study included 400 nulliparous pregnant
women with uncomplicated pregnancies with a single fetus, between October 2022 and December
2022.
Measurements and Findings:
The minimum sample size required in the study was decided by power analysis. Effect size in
the calculation: 0.35, type 1 error rate (α)=0.05, power of the study (1- β) 0.95 (Type II
error=0.05) taken as. Accordingly, the minimum number of samples to be reached was calculated
as 356 in total, and it was aimed to reach 392 samples, taking into account the 10% risk of
loss.
Research data will collect with the Data Collection Form. Noise level will measure with the
Personal Noise Dosimeter. The FHR data will collect using a cardiotocograph. Saliva cortisol
will measure by a microplate reader with commercially available kit based on ELISA.
Description:
Pregnancy is associated with psychological stress for many reasons such as physiological,
social and emotional changes. In the literature, it is thought that the stress experienced in
the prenatal period may affect maternal and fetal health primarily and secondarily. Primary
factors; It is the direct effect of increasing stress during pregnancy on biological systems
(increasing stress hormones on the body). Secondary factors are; It is an indirect effect on
maternal and fetal health as a result of unhealthy behaviors such as substance use and not
going to prenatal check-ups in pregnant women who experience stress symptoms. In both ways,
stress is associated with adverse maternal, fetal, neonatal and long-term outcomes. Prenatal
stress; It is reported to increase the risk of hypertensive diseases, placental
abnormalities, increased uterine, arterial resistance, spontaneous abortion, antenatal
bleeding, preterm labor, difficult labor, operative deliveries, postpartum depression,
intrauterine growth retardation, low APGAR Score, low birth weight and fetal death. Along
with these, maternal anxiety seemed to affect the duration and variability of the FHR, with
prolonged accelerations often fused into sustained tachycardia. A further paper reported that
the children of women who were highly anxious during pregnancy were more likely to be
hyperactive, more likely to show attention deficit, and more likely to exhibit difficult
behavior and aggression compared with children from low anxiety mothers.
Fetal heart rate (FHR) monitoring is the primary clinical technique for assessing fetal
well-being and is one of the most useful techniques for investigating fetal neurodevelopment.
In addition, FHR acceleration (defined as > 15 beats/min from baseline) is associated with
fetal movement (fetal reactivity) and has been found to have a high association with fetal
well-being.
Before 24 weeks gestation, fetal reactivity is rare, and it would seem that the appearance of
FHR reactivity is related to maturation of the central nervous system (CNS), which occurs at
the beginning of the third trimester. In research which conducted in 2010, found that fetuses
of women who had a cortisol increase following an arithmetic task versus those who did not,
had higher resting (HR) and less short-term HR variability (HRV) 20 min after the stressor
task ended. There was a trend finding for participants who had a cortisol increase to report
higher levels of life stress. In other research, higher resting maternal cortisol during the
3rd trimester was associated with greater amplitude and amount (time spent) of fetal movement
during a 50-min observation period. The aim of the present study was to determine determine
whether maternal cortisol levels affect fetal heart rate (FHR) patterns.