The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies
NCT ID: NCT06141213
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-10-01
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Ultrasound screening
Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.
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.
Ultrasound screening
Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.
Interventions
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Ultrasound screening
Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Participants who provided written informed consent for amniocentesis.
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Exclusion Criteria
2. Previous chorionic villus sampling or amniocentesis in the current pregnancy.
3. Gestational age at the time of amniocentesis greater than 25 weeks or less than 18 weeks.
4. Presence of amniotic band syndrome.
5. The presence of uterine anomalies or conditions may impact ultrasound measurements' reliability.
6. 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Tianjin Central Hospital of Gynecology Obstetrics
OTHER
Responsible Party
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Locations
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Tianjin Central Hospital of Obstetrics and Gynecology
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PLACE2102
Identifier Type: -
Identifier Source: org_study_id