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Effect of Maternal Cortisol Levels on Fetal Heart Rate Patterns

NCT05503433 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 392

Last updated 2022-08-16

No results posted yet for this study

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

Sponsors & Collaborators

  • Halic University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2022-11-01
Completion
2022-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05503433 on ClinicalTrials.gov