Intrauterine Growth Restriction (IUGR)IUGR-DVNCT07193381
Ductus Venosus Doppler in IUGR Pregnancies
An observational study of Intrauterine Growth Restriction (IUGR), run by İlayda Gercik Arzık, MD at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to evaluate the relationship between ductus venosus Doppler parameters and perinatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction (IUGR)
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Mar 2026
- How long will I take part?
- 3 Months
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women aged 18-45 years with singleton pregnancies diagnosed with intrauterine growth restriction (IUGR) will be recruited from the Department of Perinatology at Izmir City Hospital. Eligible participants will be followed with serial Doppler ultrasound examinations of the ductus venosus during the third trimester and monitored until delivery and the early neonatal period.
Who may be able to join
- Female participants aged 18-45 years
- Singleton pregnancy
- Intrauterine growth restriction (IUGR) with estimated fetal weight <10th percentile for gestational age
- Gestational age ≥24 weeks at enrollment
- Ability to comply with scheduled follow-up visits and Doppler examinations
- Signed informed consent obtained
Who cannot join
- Multiple gestations (twins or higher-order pregnancies)
- Major fetal congenital anomalies
- Known chromosomal abnormalities
- Maternal chronic systemic diseases likely to affect fetal growth (e.g., uncontrolled diabetes mellitus, severe renal disease, severe hypertension)
- Maternal infections known to impact fetal growth (e.g., TORCH infections)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Assessment of Ductus Venosus Doppler Parameters and Their Association With Perinatal Outcomes in Pregnancies With Intrauterine Growth Restriction
This prospective observational cohort study aims to evaluate the relationship between ductus venosus Doppler parameters and perinatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR). Pregnant women diagnosed with IUGR will undergo longitudinal Doppler assessments of the ductus venosus during the third trimester. The Doppler indices will be correlated with perinatal outcomes, including Apgar scores, neonatal intensive care unit (NICU) admission, and perinatal mortality. The study seeks to determine whether serial ductus venosus Doppler measurements can serve as predictive markers of adverse neonatal outcomes in IUGR pregnancies.
Read the detailed description
Intrauterine growth restriction (IUGR) is a major obstetric complication associated with increased risks of perinatal morbidity and mortality. Accurate assessment of fetal well-being and timely prediction of adverse outcomes are critical in the management of these pregnancies. The ductus venosus, a key component of the fetal circulation, reflects central venous pressure and cardiac function. Alterations in ductus venosus Doppler waveforms have been suggested as early markers of fetal compromise.
This prospective observational cohort study is designed to longitudinally evaluate ductus venosus Doppler parameters in pregnancies diagnosed with IUGR and to explore their association with perinatal outcomes. Pregnant women meeting the inclusion criteria will undergo serial Doppler examinations of the ductus venosus during the third trimester, performed at defined intervals until delivery.
Perinatal outcomes to be assessed include Apgar scores, neonatal intensive care unit (NICU) admission, duration of hospitalization, and perinatal mortality. By correlating longitudinal ductus venosus Doppler changes with clinical outcomes, the study aims to determine whether these parameters may serve as reliable predictors of neonatal risk in IUGR pregnancies. Ultimately, this research may provide additional evidence to support the use of ductus venosus Doppler in clinical decision-making and in the timing of delivery for growth-restricted fetuses.
- Conditions
- Intrauterine Growth Restriction (IUGR)
- Keywords
- Ductus Venosus, Doppler Ultrasound, Neonatal Intensive Care Unit (NICU)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IUGR Pregnancies | Pregnant women diagnosed with intrauterine growth restriction will be followed longitudinally with serial ductus venosus Doppler assessments during the third trimester. Perinatal outcomes will be recorded until delivery and the early neonatal period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse perinatal outcome (perinatal mortality, Apgar score <7 at 5 minutes, NICU admission)
A composite outcome including perinatal mortality, Apgar score <7 at 5 minutes, and NICU admission. The association between ductus venosus Doppler indices and this composite outcome will be analyzed.
Measured: From delivery until neonatal discharge (up to 28 days postpartum)
Secondary outcomes (1)
Longitudinal change (slope) of ductus venosus PI during third trimester
Rate of change per week calculated from serial weekly Doppler exams.
Measured: From study enrollment through delivery (up to 14 weeks), assessed weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth Restriction (IUGR)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- İlayda Gercik Arzık, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, İlayda Gercik Arzık, MD, Izmir City Hospital
- Investigators
- Hakan Golbasi, Assistant Professor, Study director, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193381
- Sponsor's protocol ID
- 2025/337
- Acronym
- IUGR-DV
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset is limited to a single-center observational study and will only be used for publication of aggregated results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Ductus Venosus Doppler Parameters and Their Association With Perinatal Outcomes in Pregnancies With Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT07193381
- Acronym / sponsor ID
- IUGR-DV / 2025/337
- Conditions
- Intrauterine Growth Restriction (IUGR)
- Keywords
- Ductus Venosus, Doppler Ultrasound, Neonatal Intensive Care Unit (NICU)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- İlayda Gercik Arzık, MDOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 25 Sep 2025 (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.
This prospective observational cohort study aims to evaluate the relationship between ductus venosus Doppler parameters and perinatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR). Pregnant women diagnosed with IUGR will undergo longitudinal Doppler assessments of the ductus venosus during the third trimester. The Doppler indices will be correlated with perinatal outcomes, including Apgar scores, neonatal intensive care unit (NICU) admission, and perinatal mortality. The study seeks to determine whether serial ductus venosus Doppler measurements can serve as predictive markers of adverse neonatal outcomes in IUGR pregnancies.
Detailed description
Intrauterine growth restriction (IUGR) is a major obstetric complication associated with increased risks of perinatal morbidity and mortality. Accurate assessment of fetal well-being and timely prediction of adverse outcomes are critical in the management of these pregnancies. The ductus venosus, a key component of the fetal circulation, reflects central venous pressure and cardiac function. Alterations in ductus venosus Doppler waveforms have been suggested as early markers of fetal compromise.
This prospective observational cohort study is designed to longitudinally evaluate ductus venosus Doppler parameters in pregnancies diagnosed with IUGR and to explore their association with perinatal outcomes. Pregnant women meeting the inclusion criteria will undergo serial Doppler examinations of the ductus venosus during the third trimester, performed at defined intervals until delivery.
Perinatal outcomes to be assessed include Apgar scores, neonatal intensive care unit (NICU) admission, duration of hospitalization, and perinatal mortality. By correlating longitudinal ductus venosus Doppler changes with clinical outcomes, the study aims to determine whether these parameters may serve as reliable predictors of neonatal risk in IUGR pregnancies. Ultimately, this research may provide additional evidence to support the use of ductus venosus Doppler in clinical decision-making and in the timing of delivery for growth-restricted fetuses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IUGR Pregnancies | – | –Pregnant women diagnosed with intrauterine growth restriction will be followed longitudinally with serial ductus venosus Doppler assessments during the third trimester. Perinatal outcomes will be recorded until delivery and the early neonatal period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18-45 years with singleton pregnancies diagnosed with intrauterine growth restriction (IUGR) will be recruited from the Department of Perinatology at Izmir City Hospital. Eligible participants will be followed with serial Doppler ultrasound examinations of the ductus venosus during the third trimester and monitored until delivery and the early neonatal period.
Key inclusion criteria (6 listed)
- Female participants aged 18-45 years
- Singleton pregnancy
- Intrauterine growth restriction (IUGR) with estimated fetal weight <10th percentile for gestational age
- Gestational age ≥24 weeks at enrollment
- Ability to comply with scheduled follow-up visits and Doppler examinations
Key exclusion criteria (5 listed)
- Multiple gestations (twins or higher-order pregnancies)
- Major fetal congenital anomalies
- Known chromosomal abnormalities
- Maternal chronic systemic diseases likely to affect fetal growth (e.g., uncontrolled diabetes mellitus, severe renal disease, severe hypertension)
- Maternal infections known to impact fetal growth (e.g., TORCH infections)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite adverse perinatal outcome (perinatal mortality, Apgar score <7 at 5 minutes, NICU admission)
Time frame: From delivery until neonatal discharge (up to 28 days postpartum)
A composite outcome including perinatal mortality, Apgar score <7 at 5 minutes, and NICU admission. The association between ductus venosus Doppler indices and this composite outcome will be analyzed.
1 secondary outcome
Longitudinal change (slope) of ductus venosus PI during third trimester
Time frame: From study enrollment through delivery (up to 14 weeks), assessed weekly
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 17 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset is limited to a single-center observational study and will only be used for publication of aggregated results.
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Natural History of Craniofacial Anomalies and Developmental Growth Variants
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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.
Hakan Golbasi, Assistant Professor study director
Izmir City Hospital
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 (IUGR), run by İlayda Gercik Arzık, MD 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 6 inclusion and 5 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 17 Mar 2026. 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?
Composite adverse perinatal outcome (perinatal mortality, Apgar score <7 at 5 minutes, NICU admission) (time frame: From delivery until neonatal discharge (up to 28 days postpartum)). 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 17 Mar 2026.