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NCT05503433

Effect of Maternal Cortisol Levels on Fetal Heart Rate Patterns

Status unknown Last updated 16 August 2022
What this trial tests

trial in Stress in 392 participants. Status unknown.

Timeline
1 October 2022
Primary endpoint
1 November 2022
1 December 2022

Quick facts

Lead sponsorHalic University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment392
Start date1 October 2022
Primary completion1 November 2022
Estimated completion1 December 2022

Conditions studied

Sponsor

Halic University

Who can join

Adults 18 to 35, female only, with Stress or Cortisol; Hypersecretion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of maternal cortisol levels on fetal heart rate patterns in primiparous pregnant women in the third trimester.
    Turan A, Kaya C. · · 2023 · cited 2× · PMID 37222328 · DOI 10.1590/1806-9282.20221610

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Other recruiting trials for Stress

Currently open trials in the same condition.

Other Halic University trials

Trials by the same sponsor.

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Data sources for this page

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