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StressNCT05503433

Effect of Maternal Cortisol Levels on Fetal Heart Rate Patterns

An observational study of Stress and Cortisol; Hypersecretion, run by Halic University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted16 Aug 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Nov 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

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)
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

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.

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