StressNCT05503433
Effect of Maternal Cortisol Levels on Fetal Heart Rate Patterns
An observational study of Stress and Cortisol; Hypersecretion, run by Halic University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Cortisol; Hypersecretion, Fetal Heart Rate Disorder
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In all patients, well-being and growth of the fetus should be normal and amniotic fluids were also normal.
Who may be able to join
- Voluntarily agreeing to participate in the research,
- Over 18 years old,
- Literate,
- Speaks Turkish,
- In the third trimester of pregnancy,
- Having a healthy pregnancy,
Show all 13Show fewer
- No adrenal insufficiency,
- No problems with hearing,
- No psychiatric diagnosis during or before pregnancy,
- No history of infertility,
- Coming to routine pregnancy and NST control,
- Have not had any food or drink for at least two hours before the procedure,
- Nulliparous pregnant women without contractions were included.
Who cannot join
- Pregnant women whose contractions are detected while the NST procedure is in progress,
- Pregnant women with deceleration detected in the NST procedure were excluded from the study.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Stress, Cortisol; Hypersecretion, Fetal Heart Rate Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal cortisol level of the pregnant women
About 5 ml of maternal saliva for cortisol measurements will collect at 08:00 -10:00 h and store at -80 °C until analysis. Saliva cortisol will measure by a microplate reader (Thermo Scientific Multiskan FC, 2011-06, USA) with commercially available kit based on ELISA (Human Salivary Cortisol ELISA kit-DRG international, Inc., USA, Cat Num:slv-2930).
Measured: 01.02.2021-01.10.2021
Secondary outcomes (1)
Fetal heart rate measurement
The Fetal Heart Rate data will collect using a cardiotocograph (Philips Avalon FM20).
Measured: 01.02.2021-01.10.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503433
- Sponsor's protocol ID
- FKH Parameters
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turan A, Kaya C. Effect of maternal cortisol levels on fetal heart rate patterns in primiparous pregnant women in the third trimester. Rev Assoc Med Bras (1992). 2023 May 19;69(5):e20221610. doi: 10.1590/1806-9282.20221610. eCollection 2023.
PubMed 37222328
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Cortisol Levels on Fetal Heart Rate Patterns
- ClinicalTrials.gov ID
- NCT05503433
- Acronym / sponsor ID
- FKH Parameters
- Conditions
- Stress, Cortisol; Hypersecretion, Fetal Heart Rate Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In all patients, well-being and growth of the fetus should be normal and amniotic fluids were also normal.
Key inclusion criteria (13 listed)
- Voluntarily agreeing to participate in the research,
- Over 18 years old,
- Literate,
- Speaks Turkish,
- In the third trimester of pregnancy,
Key exclusion criteria (2 listed)
- Pregnant women whose contractions are detected while the NST procedure is in progress,
- Pregnant women with deceleration detected in the NST procedure were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal cortisol level of the pregnant women
Time frame: 01.02.2021-01.10.2021
About 5 ml of maternal saliva for cortisol measurements will collect at 08:00 -10:00 h and store at -80 °C until analysis. Saliva cortisol will measure by a microplate reader (Thermo Scientific Multiskan FC, 2011-06, USA) with commercially available kit based on ELISA (Human Salivary Cortisol ELISA kit-DRG international, Inc., USA, Cat Num:slv-2930).
1 secondary outcome
Fetal heart rate measurement
Time frame: 01.02.2021-01.10.2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 37222328Turan A, Kaya C. Effect of maternal cortisol levels on fetal heart rate patterns in primiparous pregnant women in the third trimester. Rev Assoc Med Bras (1992). 2023 May 19;69(5):e20221610. doi: 10.1590/1806-9282.20221610. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Cortisol; Hypersecretion, run by Halic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal cortisol level of the pregnant women (time frame: 01.02.2021-01.10.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.