An observational study in Chromosome Aberrations, sponsored by Tianjin Central Hospital of Gynecology Obstetrics. Recruiting at 1 site in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Tianjin Central Hospital of Gynecology Obstetrics · Observational
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.
48 studies on the registry are indexed under Chromosome Aberrations; 10 are open to participants now.
This study's planned enrollment of 300 is above the median of 231 across 30 observational studies indexed under Chromosome Aberrations.
Browse Chromosome Aberrations studies →Tianjin Central Hospital of Gynecology Obstetrics is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with high-risk indications for prenatal fetal chromosomal abnormalities, including:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Ultrasound screening
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.
Diagnostic Test: Ultrasound screening
Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.
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.
Time frame: March, 2024
Started Oct 2021 (actual). Primary completion is estimated for Dec 2023, 26 months after the start.
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Tianjin Central Hospital of Gynecology Obstetrics