The Effect of Antenatal Corticosteroid on Umbilical Artery Doppler Velocimetry in IUGR

July 31, 2023 updated by: Merve Demir

The Effect of Antenatal Corticosteroid Administration on Umbilical Artery Doppler Velocimetry in Pregnant Women Complicated With IUGR

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41000
        • Merve Demir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Pregnant women treated with antenatal corticosteroid due to a possible preterm delivery were divided into two groups as complicated and uncomplicated with IUGR.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with IUGR
Pregnant women who received antenatal corticosteroid therapy and complicated with intrauterine growth retardation
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.
without IUGR
Pregnant women who received antenatal corticosteroid therapy and were not complicated by intrauterine growth retardation
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merve Demir

Collaborators

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Actual)

September 2, 2018

Study Completion (Actual)

February 2, 2019

Study Registration Dates

First Submitted

October 16, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antenatal-IUGR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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