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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05588986
Other study ID # Antenatal-IUGR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2018
Est. completion date February 2, 2019

Study information

Verified date July 2023
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effect of antenatal corticosteroid administration on umbilical artery Doppler velocimetry measurements in pregnancies complicated by IUGR.


Description:

This study was conducted with pregnant women who were likely to have preterm birth and were treated with antenatal corticosteroids. Betamethasone was used as an antenatal corticosteroid. UA Doppler measurements (PI, S/D ratio, RI) before antenatal corticosteroid administration and 24 and 48 hours after the last dose of corticosteroid administration were evaluated in pregnant groups complicated with IUGR and uncomplicated with IUGR and compared with each other.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date February 2, 2019
Est. primary completion date September 2, 2018
Accepts healthy volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids. Exclusion Criteria: Pregnant women who had complicated pregnancy with fetal anomaly, who had multiple pregnancies, who left their pregnancy follow-up unfinished, and those under 18 years of age were excluded from the study.

Study Design


Intervention

Other:
ultrasonography
Umbilical artery Doppler evaluation by ultrasonography just before the first dose of antenatal corticosteroid, 24 hours and 48 hours after the last dose.

Locations

Country Name City State
Turkey Merve Demir Kocaeli

Sponsors (2)

Lead Sponsor Collaborator
Merve Demir Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary systolic:diastolic ratio (S/D ratio) Peak systolic velocity/end diastolic velocity 2018-2019
Primary pulsatility index (PI) Pulsatility Index (PI) = (Peak systolic velocity - end diastolic velocity)/(time averaged maximum velocity) 2018-2019
Primary Resistive Index (RI) Resistive Index (RI) = (Peak systolic velocity - end diastolic velocity)/(peak systolic velocity) 2018-2019
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