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

• Sponsor: Merve Demir (Other)
• Overall Status: Completed
• CT.gov ID: NCT05588986
• Collaborator: Marmara University (Other)
• Enrollment: 149
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Growth Restriction	Other: ultrasonography

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 Design

• Study Type: Observational
• Actual Enrollment: 149 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Effect of Antenatal Corticosteroid Administration on Umbilical Artery Doppler Velocimetry in Pregnant Women Complicated With IUGR
• Actual Study Start Date: Feb 2, 2018
• Actual Primary Completion Date: Sep 2, 2018
• Actual Study Completion Date: Feb 2, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. systolic:diastolic ratio (S/D ratio) [2018-2019]

   Peak systolic velocity/end diastolic velocity

2. pulsatility index (PI) [2018-2019]

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

3. Resistive Index (RI) [2018-2019]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merve Demir	Kocaeli		Turkey	41000

Sponsors and Collaborators

• Merve Demir
• Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merve Demir, Research assistant, Kocaeli University
• ClinicalTrials.gov Identifier: NCT05588986
• Other Study ID Numbers: Antenatal-IUGR
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fetal Growth Retardation

Study Results

No Results Posted as of Oct 20, 2022