Intrauterine Growth RestrictionNCT05588986
The Effect of Antenatal Corticosteroid on Umbilical Artery Doppler Velocimetry in IUGR
An observational study of Intrauterine Growth Restriction, run by Merve Demir at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- ultrasonography
- How many people
- 149 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2018to 2 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Adult
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.
Who may be able to join
- pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- ultrasonography
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyOther
Umbilical artery Doppler evaluation by ultrasonography just before the first dose of antenatal corticosteroid, 24 hours and 48 hours after the last dose.
| Study group | Role | What they receive |
|---|---|---|
| with IUGR | Pregnant women who received antenatal corticosteroid therapy and complicated with intrauterine growth retardation Receives: Other: ultrasonography | |
| without IUGR | Pregnant women who received antenatal corticosteroid therapy and were not complicated by intrauterine growth retardation Receives: Other: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic:diastolic ratio (S/D ratio)
Peak systolic velocity/end diastolic velocity
Measured: 2018-2019
pulsatility index (PI)
Pulsatility Index (PI) = (Peak systolic velocity - end diastolic velocity)/(time averaged maximum velocity)
Measured: 2018-2019
Resistive Index (RI)
Resistive Index (RI) = (Peak systolic velocity - end diastolic velocity)/(peak systolic velocity)
Measured: 2018-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start2 Feb 2018
- Primary completion2 Sep 2018
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Demir
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Sponsor-investigator, Merve Demir, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588986
- Sponsor's protocol ID
- Antenatal-IUGR
- Status last verified
- Jul 2023
- First submitted
- 16 Oct 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antenatal Corticosteroid Administration on Umbilical Artery Doppler Velocimetry in Pregnant Women Complicated With IUGR
- ClinicalTrials.gov ID
- NCT05588986
- Acronym / sponsor ID
- Antenatal-IUGR
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Merve DemirUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with IUGR | – | Other: ultrasonographyPregnant women who received antenatal corticosteroid therapy and complicated with intrauterine growth retardation |
| without IUGR | – | Other: ultrasonographyPregnant women who received antenatal corticosteroid therapy and were not complicated by intrauterine growth retardation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyUmbilical artery Doppler evaluation by ultrasonography just before the first dose of antenatal corticosteroid, 24 hours and 48 hours after the last dose. | Other | with IUGR, without IUGR |
Primary outcome
systolic:diastolic ratio (S/D ratio)
Time frame: 2018-2019
Peak systolic velocity/end diastolic velocity
pulsatility index (PI)
Time frame: 2018-2019
Pulsatility Index (PI) = (Peak systolic velocity - end diastolic velocity)/(time averaged maximum velocity)
Resistive Index (RI)
Time frame: 2018-2019
Resistive Index (RI) = (Peak systolic velocity - end diastolic velocity)/(peak systolic velocity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Merve Demir at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic:diastolic ratio (S/D ratio) (time frame: 2018-2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.