The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

Recruiting

• Conditions: Chromosome Aberrations
• Interventions: Diagnostic Test: Ultrasound screening

• Registration Number: NCT06141213
• Lead Sponsor: Tianjin Central Hospital of Gynecology Obstetrics

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abnormal fetal chromosomes	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.
Normal fetal chromosomes	Ultrasound screening	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.

Primary Outcome Measures

Name	Time	Method
Correlation Between Fetal Membrane Thickness and Chromosomal Abnormalities	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.

Trial Locations

Locations (1)

Tianjin Central Hospital of Obstetrics and Gynecology; 🇨🇳 Tianjin, Tianjin, China