Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening AccuracyNCT07165743
Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities
An observational study of Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Template-Based Brief Summary (Sağlık Profesyonelleri İçin) Study Title: The Negative Predictive Value of First-Trimester Fetal Bladder "Rapid Emptying" (≤40 minutes and post-void ≤2 mm) for Major Chromosomal Aneuploidies: A Prospective Diagnostic Accuracy Study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
- What is being tested?
- 40-Minute Real-Time First-Trimester Ultrasonography
- How many people
- 270 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 30 Jan 2026
- How long will I take part?
- 270 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Study population: Prospective cohort of 270 consecutive healthy pregnant women with singleton fetuses, attending first-trimester screening (11 - 14 GA) at a tertiary perinatology center in Istanbul, Türkiye.
Who may be able to join
- Singleton, viable pregnancy between 11 + 0 and 14 + 0 gestational weeks (GA)
- Maternal age 18 - 45 years at enrollment
- Able to provide written informed consent
Who cannot join
- Multiple gestation (twins, higher order)
- Major fetal structural anomaly detected at index scan
- Known serious maternal comorbidity (e.g., insulin-dependent diabetes, uncontrolled hypertension, renal or autoimmune disease)
- Participation in another interventional research study during the current pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Haseki Training and Research Hospital - Perinatology Department
Istanbul, Istanbul (Sultangazi District), 34265
About this study
Official title: Negative Predictive Value of Rapid Emptying of the Fetal Bladder (≤40 Min and Post-void ≤2 mm) on Major Chromosome Aneuploidies at 11-14 Gestational Weeks: A Prospective Diagnostic Accuracy Study
Template-Based Brief Summary (Sağlık Profesyonelleri İçin)
Study Title:
Read more
The Negative Predictive Value of First-Trimester Fetal Bladder "Rapid Emptying" (≤40 minutes and post-void ≤2 mm) for Major Chromosomal Aneuploidies: A Prospective Diagnostic Accuracy Study.
Purpose:
To evaluate whether the dynamic phenotype of rapid bladder emptying at 11-14 weeks reduces the likelihood of major chromosomal abnormalities (particularly Trisomy 21) compared to fetuses without this phenotype.
Design:
Single-center, prospective observational cohort.
Population:
270 singleton pregnancies between 11+0 and 14+0 weeks.
Procedures:
Real-time sagittal ultrasound observation for 40 minutes.
Documentation of bladder emptying time and post-void longitudinal bladder diameter.
Concurrent measurement of CRL, NT, ductus venosus waveform.
Gold standard confirmation with cfDNA or invasive karyotyping in high-risk cases.
Primary Endpoint:
Negative predictive value (NPV), ROC-AUC, sensitivity/specificity for aneuploidy detection.
Secondary Endpoints:
Rate of invasive testing, performance in combined models with cfDNA and biophysical markers, Net Reclassification Index.
Duration:
5 months (08/2025 - 01/2026).
Potential Impact:
If validated, the rapid emptying phenotype may serve as a low-risk marker, reduce unnecessary invasive procedures, and refine first-trimester screening algorithms.
- Conditions
- Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
- Being tested
- 40-Minute Real-Time First-Trimester Ultrasonography
- Keywords
- First-trimester screening Chromosomal abnormalities Prenatal diagnosis Ultrasound Negative predictive value (NPV) Fetal bladder
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40-Minute Real-Time First-Trimester UltrasonographyDiagnostic test
A one-time midsagittal ultrasound performed between 11 +0 and 14 +0 weeks. Bladder emptying time and post-void longitudinal bladder diameter are recorded. No invasive procedures are performed.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies in which the fetal bladder empties completely within ≤ 40 minutes | Not described Receives: Diagnostic Test: 40-Minute Real-Time First-Trimester Ultrasonography | |
| Pregnancies in which the bladder does not meet the rapid-emptying criteria | Not described Receives: Diagnostic Test: 40-Minute Real-Time First-Trimester Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value (NPV) of Rapid Fetal Bladder Emptying for Detecting Major Chromosomal Aneuploidy
Proportion of fetuses with the rapid-emptying phenotype (≤ 40-minute complete emptying + post-void longitudinal bladder diameter ≤ 2 mm) who are subsequently confirmed not to have a major chromosomal aneuploidy (Trisomy 21, 18, or 13) by cfDNA, invasive karyotype, or postnatal testing.
Measured: From enrollment at 11 + 0 to 14 + 0 gestational weeks until definitive genetic result or delivery, whichever comes first (≈ 26 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start28 Aug 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening AccuracyStudies 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
- Cross-sectional
- Enrolment
- 270 participants (estimated)
- Target duration
- 270 Months
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can Bilginer, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165743
- Sponsor's protocol ID
- HasekiTRH 27.08.2025 155-2025
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses-including fetal bladder emptying time, post-void longitudinal bladder diameter, nuchal translucency, ductus venosus waveform, cfDNA results, and karyotype confirmation-will be shared with qualified researchers upon reasonable request.
Publications
Arasaratnam M, Balakrishnar B, Crumbaker M, Turner S, Hayden AJ, Brooks A, Patel MI, Lau H, Woo H, Bariol S, Gurney H. Patterns of care and outcomes of men with germ cell tumors in a high-volume Australian center. Asia Pac J Clin Oncol. 2022 Apr;18(2):e23-e31. doi: 10.1111/ajco.13548. Epub 2021 Jun 21.
PubMed 34152083Muller K, Kufner K, Prange K, Bengel J. [Screening for Anxiety in People with an Intellectual Disability: German Version of the "Glasgow Anxiety Scale for People with an Intellectual Disability" (GAS-ID)]. Psychiatr Prax. 2019 Jul;46(5):274-280. doi: 10.1055/a-0843-3373. Epub 2019 Mar 19. German.
PubMed 30891726Zhu R, Lv W, Sun C, Qin C, Zhang D, Long Z. A facile strategy to fabricate high-barrier, water- and oil-repellent paper with carboxymethyl cellulose/collagen fiber/modified polyvinyl alcohol. Carbohydr Polym. 2023 Aug 15;314:120933. doi: 10.1016/j.carbpol.2023.120933. Epub 2023 Apr 20.
PubMed 37173031Savarese JJ, Tabler NG Jr. Multimodal analgesia as an alternative to the risks of opioid monotherapy in surgical pain management. J Healthc Risk Manag. 2017 Jul;37(1):24-30. doi: 10.1002/jhrm.21262.
PubMed 28719091Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.
PubMed 27671006Capone V, Persico N, Berrettini A, Decramer S, De Marco EA, De Palma D, Familiari A, Feitz W, Herthelius M, Kazlauskas V, Liebau M, Manzoni G, Maternik M, Mosiello G, Schanstra JP, Vande Walle J, Wuhl E, Ylinen E, Zurowska A, Schaefer F, Montini G. Definition, diagnosis and management of fetal lower urinary tract obstruction: consensus of the ERKNet CAKUT-Obstructive Uropathy Work Group. Nat Rev Urol. 2022 May;19(5):295-303. doi: 10.1038/s41585-022-00563-8. Epub 2022 Feb 8.
PubMed 35136187Lesieur E, Barrois M, Bourdon M, Blanc J, Loeuillet L, Delteil C, Torrents J, Bretelle F, Grange G, Tsatsaris V, Anselem O. Megacystis in the first trimester of pregnancy: Prognostic factors and perinatal outcomes. PLoS One. 2021 Sep 7;16(9):e0255890. doi: 10.1371/journal.pone.0255890. eCollection 2021.
PubMed 34492029
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Predictive Value of Rapid Emptying of the Fetal Bladder (≤40 Min and Post-void ≤2 mm) on Major Chromosome Aneuploidies at 11-14 Gestational Weeks: A Prospective Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT07165743
- Acronym / sponsor ID
- HasekiTRH 27.08.2025 155-2025
- Conditions
- Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
- Keywords
- First-trimester screening Chromosomal abnormalities Prenatal diagnosis Ultrasound Negative predictive value (NPV) Fetal bladder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 10 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.
Template-Based Brief Summary (Sağlık Profesyonelleri İçin)
Study Title:
The Negative Predictive Value of First-Trimester Fetal Bladder "Rapid Emptying" (≤40 minutes and post-void ≤2 mm) for Major Chromosomal Aneuploidies: A Prospective Diagnostic Accuracy Study.
Purpose:
To evaluate whether the dynamic phenotype of rapid bladder emptying at 11-14 weeks reduces the likelihood of major chromosomal abnormalities (particularly Trisomy 21) compared to fetuses without this phenotype.
Design:
Single-center, prospective observational cohort.
Population:
270 singleton pregnancies between 11+0 and 14+0 weeks.
Procedures:
Real-time sagittal ultrasound observation for 40 minutes.
Documentation of bladder emptying time and post-void longitudinal bladder diameter.
Concurrent measurement of CRL, NT, ductus venosus waveform.
Gold standard confirmation with cfDNA or invasive karyotyping in high-risk cases.
Primary Endpoint:
Negative predictive value (NPV), ROC-AUC, sensitivity/specificity for aneuploidy detection.
Secondary Endpoints:
Rate of invasive testing, performance in combined models with cfDNA and biophysical markers, Net Reclassification Index.
Duration:
5 months (08/2025 - 01/2026).
Potential Impact:
If validated, the rapid emptying phenotype may serve as a low-risk marker, reduce unnecessary invasive procedures, and refine first-trimester screening algorithms.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 270 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancies in which the fetal bladder empties completely within ≤ 40 minutes | – | Diagnostic Test: 40-Minute Real-Time First-Trimester Ultrasonography |
| Pregnancies in which the bladder does not meet the rapid-emptying criteria | – | Diagnostic Test: 40-Minute Real-Time First-Trimester Ultrasonography |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Prospective cohort of 270 consecutive healthy pregnant women with singleton fetuses, attending first-trimester screening (11 - 14 GA) at a tertiary perinatology center in Istanbul, Türkiye.
Key inclusion criteria (3 listed)
- Singleton, viable pregnancy between 11 + 0 and 14 + 0 gestational weeks (GA)
- Maternal age 18 - 45 years at enrollment
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Multiple gestation (twins, higher order)
- Major fetal structural anomaly detected at index scan
- Known serious maternal comorbidity (e.g., insulin-dependent diabetes, uncontrolled hypertension, renal or autoimmune disease)
- Participation in another interventional research study during the current pregnancy
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 |
|---|---|---|
| 40-Minute Real-Time First-Trimester UltrasonographyA one-time midsagittal ultrasound performed between 11 +0 and 14 +0 weeks. Bladder emptying time and post-void longitudinal bladder diameter are recorded. No invasive procedures are performed. | Diagnostic test | Pregnancies in which the bladder does not meet the rapid-emptying criteria, Pregnancies in which the fetal bladder empties completely within ≤ 40 minutes |
Primary outcome
Negative Predictive Value (NPV) of Rapid Fetal Bladder Emptying for Detecting Major Chromosomal Aneuploidy
Time frame: From enrollment at 11 + 0 to 14 + 0 gestational weeks until definitive genetic result or delivery, whichever comes first (≈ 26 weeks).
Proportion of fetuses with the rapid-emptying phenotype (≤ 40-minute complete emptying + post-void longitudinal bladder diameter ≤ 2 mm) who are subsequently confirmed not to have a major chromosomal aneuploidy (Trisomy 21, 18, or 13) by cfDNA, invasive karyotype, or postnatal testing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 34152083Arasaratnam M, Balakrishnar B, Crumbaker M, Turner S, Hayden AJ, Brooks A, Patel MI, Lau H, Woo H, Bariol S, Gurney H. Patterns of care and outcomes of men with germ cell tumors in a high-volume Australian center. Asia Pac J Clin Oncol. 2022 Apr;18(2):e23-e31. doi: 10.1111/ajco.13548. Epub 2021 Jun 21.
- Background: PubMed 30891726Muller K, Kufner K, Prange K, Bengel J. [Screening for Anxiety in People with an Intellectual Disability: German Version of the "Glasgow Anxiety Scale for People with an Intellectual Disability" (GAS-ID)]. Psychiatr Prax. 2019 Jul;46(5):274-280. doi: 10.1055/a-0843-3373. Epub 2019 Mar 19. German.
- Background: PubMed 37173031Zhu R, Lv W, Sun C, Qin C, Zhang D, Long Z. A facile strategy to fabricate high-barrier, water- and oil-repellent paper with carboxymethyl cellulose/collagen fiber/modified polyvinyl alcohol. Carbohydr Polym. 2023 Aug 15;314:120933. doi: 10.1016/j.carbpol.2023.120933. Epub 2023 Apr 20.
- Background: PubMed 28719091Savarese JJ, Tabler NG Jr. Multimodal analgesia as an alternative to the risks of opioid monotherapy in surgical pain management. J Healthc Risk Manag. 2017 Jul;37(1):24-30. doi: 10.1002/jhrm.21262.
- Background: PubMed 27671006Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.
- Results publication: PubMed 35136187Capone V, Persico N, Berrettini A, Decramer S, De Marco EA, De Palma D, Familiari A, Feitz W, Herthelius M, Kazlauskas V, Liebau M, Manzoni G, Maternik M, Mosiello G, Schanstra JP, Vande Walle J, Wuhl E, Ylinen E, Zurowska A, Schaefer F, Montini G. Definition, diagnosis and management of fetal lower urinary tract obstruction: consensus of the ERKNet CAKUT-Obstructive Uropathy Work Group. Nat Rev Urol. 2022 May;19(5):295-303. doi: 10.1038/s41585-022-00563-8. Epub 2022 Feb 8.
- Results publication: PubMed 34492029Lesieur E, Barrois M, Bourdon M, Blanc J, Loeuillet L, Delteil C, Torrents J, Bretelle F, Grange G, Tsatsaris V, Anselem O. Megacystis in the first trimester of pregnancy: Prognostic factors and perinatal outcomes. PLoS One. 2021 Sep 7;16(9):e0255890. doi: 10.1371/journal.pone.0255890. eCollection 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses-including fetal bladder emptying time, post-void longitudinal bladder diameter, nuchal translucency, ductus venosus waveform, cfDNA results, and karyotype confirmation-will be shared with qualified researchers upon reasonable request.
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 Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy, run by Haseki Training and Research Hospital 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Negative Predictive Value (NPV) of Rapid Fetal Bladder Emptying for Detecting Major Chromosomal Aneuploidy (time frame: From enrollment at 11 + 0 to 14 + 0 gestational weeks until definitive genetic result or delivery, whichever comes first (≈ 26 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165743, which also lists 7 linked publications.
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 10 Sep 2025.