NCT05588986

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

October 16, 2022

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • systolic:diastolic ratio (S/D ratio)

    Peak systolic velocity/end diastolic velocity

    2018-2019

  • pulsatility index (PI)

    Pulsatility Index (PI) = (Peak systolic velocity - end diastolic velocity)/(time averaged maximum velocity)

    2018-2019

  • Resistive Index (RI)

    Resistive Index (RI) = (Peak systolic velocity - end diastolic velocity)/(peak systolic velocity)

    2018-2019

Study Arms (2)

with IUGR

Pregnant women who received antenatal corticosteroid therapy and complicated with intrauterine growth retardation

Other: ultrasonography

without IUGR

Pregnant women who received antenatal corticosteroid therapy and were not complicated by intrauterine growth retardation

Other: ultrasonography

Interventions

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

with IUGRwithout IUGR

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Demir

Kocaeli, 41000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

October 16, 2022

First Posted

October 20, 2022

Study Start

February 2, 2018

Primary Completion

September 2, 2018

Study Completion

February 2, 2019

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations