The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

Chromosome Aberrations Clinical Trial

— PLACE2102  

Official title:

The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141213
• Other study ID #: PLACE2102
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Tianjin Central Hospital of Gynecology Obstetrics
• Contact: Jiasong Cao, PhD
• Phone: +86 13662046469
• Email: caojiasong[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Singleton pregnant women between 18-24 weeks of gestation.

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. -

Exclusion Criteria:

1. Women with multiple pregnancies or higher-order births.

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.

Related Conditions & MeSH terms

• Aneuploidy
• Chromosome Aberrations

Intervention

Diagnostic Test:
• Ultrasound screening
Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.

Locations

Country	Name	City	State
China	Tianjin Central Hospital of Obstetrics and Gynecology	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Central Hospital of Gynecology Obstetrics

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	March, 2024