Effect of Maternal Cortisol Levels on Fetal Heart Rate Patterns

NCT05503433 | Unknown

• 1 other identifier: FKH Parameters
• Study Type: observational
• Target: 392
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress; Cortisol; Hypersecretion; Fetal Heart Rate Disorder

Outcome Measures

Primary Outcomes (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).

  01.02.2021-01.10.2021

Secondary Outcomes (1)

• Fetal heart rate measurement

  01.02.2021-01.10.2021

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Nulliparous pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

In all patients, well-being and growth of the fetus should be normal and amniotic fluids were also normal.

You may qualify if:

• Voluntarily agreeing to participate in the research,
• Over 18 years old,
• Literate,
• Speaks Turkish,
• In the third trimester of pregnancy,
• Having a healthy pregnancy,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

Related Publications (1)

• 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.

  PMID: 37222328 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 16, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08