Chromosome AberrationsPLACE2102NCT06141213
The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies
An observational study of Chromosome Aberrations, run by Tianjin Central Hospital of Gynecology Obstetrics at 1 site in China.
Trial summary
This observational study aims to recruit pregnant women between 18 to 24 weeks of gestation to investigate the relationship between amniotic membrane thickness and fetal chromosomal abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chromosome Aberrations
- What is being tested?
- Ultrasound screening
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Aug 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population included pregnant women referred to the Center for Prenatal Diagnosis and Fetal Medicine at Tianjin Central Hospital of Obstetrics and Gynecology. These participants were identified based on clinical indicators of elevated risk for fetal chromosomal abnormalities. The cohort represented a diverse age range of expectant mothers, predominantly from Tianjin's urban and suburban regions in China. Focused on singleton pregnancies, the study minimizes variables linked to the complexities of multiple gestations. The women were chiefly in their second trimester, a pivotal time for fetal development and diagnostic evaluation. A considerable portion of the study participants had received high-risk NIPT results or demonstrated ultrasound markers suggesting potential chromosomal irregularities. This selection was vital for evaluating FM thickness as a diagnostic tool for chromosomal anomalies.
Who may be able to join
- Singleton pregnant women between 18-24 weeks of gestation.
- Participants with high-risk indications for prenatal fetal chromosomal abnormalities, including:
- Nuchal translucency (NT) ≥ 3 mm.
- High-risk results from non-invasive prenatal testing (NIPT) using cell-free fetal DNA from peripheral maternal blood.
- Ultrasound-detected fetal abnormalities.
- Other indicators include adverse birth histories, parental chromosomal abnormalities, familial diseases, and a history of thyroid cancer post-surgery.
Show all 9Show fewer
- Gestational age and estimated due date were confirmed by the first day of the last menstrual period and adjusted using fetal crown-rump length measured during the first-trimester ultrasound scan.
- Participants who provided written informed consent for amniocentesis.
- -
Who cannot join
- Women with multiple pregnancies or higher-order births.
- Previous chorionic villus sampling or amniocentesis in the current pregnancy.
- Gestational age at the time of amniocentesis greater than 25 weeks or less than 18 weeks.
- Presence of amniotic band syndrome.
- The presence of uterine anomalies or conditions may impact ultrasound measurements' reliability.
- Any medical condition or obstetric complication that, in the opinion of the investigators, might pose a risk to the participant or interfere with the study outcomes.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Central Hospital of Obstetrics and Gynecology
Tianjin, Tianjin Municipality, 300100
Ying Chang, PhD, +8602258287905, changying_4470@tju.edu.cn
About this study
This observational study aims to recruit pregnant women between 18 to 24 weeks of gestation to investigate the relationship between amniotic membrane thickness and fetal chromosomal abnormalities. The primary objectives are to establish whether a correlation exists between the measured thickness of the amniotic membrane and the presence of chromosomal abnormalities in the fetus, and to determine a cutoff value for amniotic membrane thickness that could indicate an increased risk of such abnormalities. Additionally, the study seeks to assess whether the inclusion of amniotic membrane thickness as a biomarker can enhance the detection rate of non-invasive prenatal testing (NIPT) and nuchal translucency (NT) for chromosomal abnormalities.
- Conditions
- Chromosome Aberrations
- Being tested
- Ultrasound screening
- Keywords
- Fetal membrane, Fetal chromosomal abnormalities, Ultrasound screening
- Medical subject headings
- Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound screeningDiagnostic test
Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Normal fetal chromosomes | This group will consist of participants with confirmed normal fetal chromosomes.
Fetal membrane thickness measurements will be taken at enrollment and may be followed up with subsequent measurements throughout the pregnancy.
The data from this group will serve as the control for comparison with the chromosomal abnormality group. Receives: Diagnostic Test: Ultrasound screening | |
| Abnormal fetal chromosomes | This group will include participants whose fetuses have been diagnosed with chromosomal abnormalities.
These participants will also have their fetal membrane thickness measured at the same gestational age as the control group to ensure consistency.
The comparison of fetal membrane thickness between this group and the control group will be a primary focus of the study. Receives: Diagnostic Test: Ultrasound screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Fetal Membrane Thickness and Chromosomal Abnormalities
The difference in mean fetal membrane thickness between the normal and abnormal chromosomal groups, and the establishment of a threshold value for risk assessment.
Measured: March, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosome AberrationsStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Central Hospital of Gynecology Obstetrics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141213
- Sponsor's protocol ID
- PLACE2102
- Acronym
- PLACE2102
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies
- ClinicalTrials.gov ID
- NCT06141213
- Acronym / sponsor ID
- PLACE2102 / PLACE2102
- Conditions
- Chromosome Aberrations
- Keywords
- Fetal membrane, Fetal chromosomal abnormalities, Ultrasound screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Central Hospital of Gynecology ObstetricsUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 21 Nov 2023 (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 observational study aims to recruit pregnant women between 18 to 24 weeks of gestation to investigate the relationship between amniotic membrane thickness and fetal chromosomal abnormalities. The primary objectives are to establish whether a correlation exists between the measured thickness of the amniotic membrane and the presence of chromosomal abnormalities in the fetus, and to determine a cutoff value for amniotic membrane thickness that could indicate an increased risk of such abnormalities. Additionally, the study seeks to assess whether the inclusion of amniotic membrane thickness as a biomarker can enhance the detection rate of non-invasive prenatal testing (NIPT) and nuchal translucency (NT) for chromosomal abnormalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal fetal chromosomes | – | Diagnostic Test: Ultrasound screeningThis group will consist of participants with confirmed normal fetal chromosomes. Fetal membrane thickness measurements will be taken at enrollment and may be followed up with subsequent measurements throughout the pregnancy. The data from this group will serve as the control for comparison with the chromosomal abnormality group. |
| Abnormal fetal chromosomes | – | Diagnostic Test: Ultrasound screeningThis group will include participants whose fetuses have been diagnosed with chromosomal abnormalities. These participants will also have their fetal membrane thickness measured at the same gestational age as the control group to ensure consistency. The comparison of fetal membrane thickness between this group and the control group will be a primary focus of the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population included pregnant women referred to the Center for Prenatal Diagnosis and Fetal Medicine at Tianjin Central Hospital of Obstetrics and Gynecology. These participants were identified based on clinical indicators of elevated risk for fetal chromosomal abnormalities. The cohort represented a diverse age range of expectant mothers, predominantly from Tianjin's urban and suburban regions in China. Focused on singleton pregnancies, the study minimizes variables linked to the complexities of multiple gestations. The women were chiefly in their second trimester, a pivotal time for fetal development and diagnostic evaluation. A considerable portion of the study participants had received high-risk NIPT results or demonstrated ultrasound markers suggesting potential chromosomal irregularities. This selection was vital for evaluating FM thickness as a diagnostic tool for chromosomal anomalies.
Key inclusion criteria (9 listed)
- Singleton pregnant women between 18-24 weeks of gestation.
- Participants with high-risk indications for prenatal fetal chromosomal abnormalities, including:
- Gestational age and estimated due date were confirmed by the first day of the last menstrual period and adjusted using fetal crown-rump length measured during the first-trimester ultrasound scan.
- Participants who provided written informed consent for amniocentesis.
- -
Key exclusion criteria (6 listed)
- Women with multiple pregnancies or higher-order births.
- Previous chorionic villus sampling or amniocentesis in the current pregnancy.
- Gestational age at the time of amniocentesis greater than 25 weeks or less than 18 weeks.
- Presence of amniotic band syndrome.
- The presence of uterine anomalies or conditions may impact ultrasound measurements' reliability.
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 |
|---|---|---|
| Ultrasound screeningUltrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy. | Diagnostic test | Abnormal fetal chromosomes, Normal fetal chromosomes |
Primary outcome
Correlation Between Fetal Membrane Thickness and Chromosomal Abnormalities
Time frame: March, 2024
The difference in mean fetal membrane thickness between the normal and abnormal chromosomal groups, and the establishment of a threshold value for risk assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
Related trials for Chromosome Aberrations
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Not yet recruitingPhase 3
A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
RecruitingPhase 1/2
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
B-NHL, B-Non Hodgkin Lymphoma
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
RecruitingPhase 1
A Study of Sovilnesib in Subjects With Ovarian Cancer
High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer
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.
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 Chromosome Aberrations, run by Tianjin Central Hospital of Gynecology Obstetrics at 1 site in China.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Nov 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiasong Cao, PhD (+86 13662046469, caojiasong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Fetal Membrane Thickness and Chromosomal Abnormalities (time frame: March, 2024). 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 21 Nov 2023.