Status:
UNKNOWN
The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies
Lead Sponsor:
Tianjin Central Hospital of Gynecology Obstetrics
Conditions:
Chromosome Aberrations
Eligibility:
FEMALE
18-50 years
Brief 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. The...
Eligibility Criteria
Inclusion
- 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.
- 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.
- \-
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06141213
Start Date
October 1 2021
End Date
August 31 2024
Last Update
November 21 2023
Active Locations (1)
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1
Tianjin Central Hospital of Obstetrics and Gynecology
Tianjin, Tianjin Municipality, China, 300100